Evaluation report

Hospira Plum A+ volumetric

infusion pump
CEP 07014

October 2007
Contents 2

Executive summary .................................................................................. 3

Introduction............................................................................................... 5

Product description................................................................................... 6

Evaluation method.................................................................................... 9

Technical performance........................................................................... 10

Operational considerations..................................................................... 15

Economic considerations ....................................................................... 20

Purchasing ............................................................................................. 22

Conclusions............................................................................................ 23

References ............................................................................................. 24

Appendix ................................................................................................ 25

Author and report information................................................................. 32

CEP 07014: 2007

Executive summary 3

The product
The Hospira Pump A+ is a volumetric infusion pump with a number of innovative features,
including concurrent delivery and an air-in-line detection-and-removal facility. Standard,
piggyback and concurrent deliveries are made possible by a special pumping cassette that
allows two fluids to be delivered at separate flow rates via a single line to the patient. The
design also enables delivery of drugs from syringes on all standard sets. The cassette
features a novel chamber that traps air and facilitates its removal from the fluid pathway
without disconnecting from the patient. The pumping mechanism is designed to resist
changes in delivery accuracy resulting from changes in fluid container height.

Field of use
The pump is designed for use in a range of ward environments including general wards and
critical care settings. Delivery of parenteral, enteral or epidural infusions is possible.
Intravenous deliveries can include fluids, drugs, nutrition, blood and blood products.

Evaluation method
Technical testing has been limited to the innovative features of the pump: concurrent
delivery of two fluids through a single line, delivery accuracy when the container height is
changed, and air detection, trapping and removal. A user survey was conducted at three
NHS Trust sites, using a questionnaire and follow-up interviews. Laboratory-based usability
studies were performed to identify areas where users might encounter problems. Additional
information was provided by the manufacturer relating to device features, training, pricing,
sustainability issues, and support for servicing and maintenance.

Technical performance
The pump was tested to measure delivery accuracy when two fluids are infusing at the same
time. Delivery accuracy remained within +/-5% of the set rate throughout each phase of the
test, indicating that the pump is able to start and stop a second delivery accurately and that
each drug is delivered at the expected rate. The Hospira Plum A+ features a novel air-
detection system. Air was artificially introduced into the system. The alarm sounded when a
sufficient volume of air had been introduced into the system. The alarm was triggered after
an average of 1.3ml had been introduced. It is claimed that the delivery system is virtually
independent of the fluid container position. To test this claim, the pump was set to run for
five hours at a delivery rate of 125 ml/h. During this time, the fluid container was set first at a
normal height (about 30 cm above the pump), then raised to a high position (about 60 cm
above the pump) and then finally lowered to a position about 25 cm below the pump. The
delivery accuracy remained excellent throughout the test.

The laboratory-based usability assessment was conducted by evaluators who independently

performed a series of clinically typical tasks.

From this assessment, the results demonstrated good overall performance in terms of
usability; the pump and its available features can be considered relatively easy to use. Of

CEP 07014: 2007

Executive summary 4

the negative issues identified, five were rated as major, while the great majority were rated
as minor or cosmetic in nature. A number of positive points were also recorded, indicating
instances of good design with respect to usability.

Operational considerations
In some clinical settings, multiple drugs will regularly need to be delivered simultaneously. If
the drugs have flow-rate requirements and compatibilities that match the capabilities of the
Plum A+, cost savings associated with using fewer devices and inexpensive secondary
administration sets may be significant.

The facility of delivering a drug from a syringe at a controlled flow rate may prove useful in
several clinical areas. When delivering chemotherapy drugs for example, there may be a
tendency to deliver the drugs more rapidly manually than is recommended. The ability to use
a pump to control such deliveries and ensure they are given correctly may provide useful.

The pump may be suitable in cases where excellent accuracy needs to be maintained
despite a reduced or changing fluid container height. Transport applications (ambulances)
and homecare parenteral nutrition are two examples where this performance feature may be
relevant.

CEP verdict
The Hospira Plum A+ has performed well in evaluation, showing both accurate technical
performance and good usability, with clear displays and logical programming steps.

Its abilities to deliver two fluids simultaneously through a single line and to deliver drugs from
syringes may offer practical advantages in some clinical settings and may lead to potential
cost savings.

Facilities for safely trapping and removing air-in-line are effective and useful. The ability to
deliver fluid accurately despite changes in fluid container height may also be advantageous
in some settings.

The pump does not yet offer advanced dose limiting software, but this is offered on the same
device in the USA and it is expected to be introduced in the UK in 2008. The pump is
designed to allow relatively easy upgrades of this nature through a simple card change.

CEP 07014: 2007

Introduction 5

This CEP evaluation report concerns the Hospira Plum A+ volumetric infusion pump. It
includes technical testing, an assessment of device usability, a clinical user survey, and
detailed consideration of other operational and purchasing issues.

Volumetric infusion pumps are used in a wide range of hospital settings. They are used for
the controlled administration of fluids and drugs, generally via the intravenous (IV) route.
Comprehensive audible and visible alarms are provided on pumps to alert clinicians in the
event of undesirable events, such as air within the administration set or a blockage
(occlusion) in the fluid pathway. Requirements for performance and safety systems for
infusion pumps are governed by the international standard IEC 60601-2-24 [1].

In recent years, there have been advances in the use of software to promote safer drug
administration, including dose limitation software, bar coding facilities, and integration with
hospital information management systems. These features are designed to reduce the
likelihood of drug administration errors by including additional automated guards against
inappropriate dose settings and other hazards.

Volumetric pumps are suitable for delivering relatively large volumes of fluid at an accurately
controlled flow rate. The nature of the pumping mechanism results in a somewhat erratic
fluid delivery from minute to minute if the flow rate is low (e.g. 5 ml/h or less). If smooth
delivery of fluid is required at very low flow rates (for example, when using fast-acting
vasoactive drugs in a critical care setting) the use of a syringe pump may be more
appropriate, since these can offer a more even fluid delivery profile. However, appropriate
device selection is a complex issue, and local policies should be followed.

Rationalisation of the range of different pumps available in a hospital setting can have a
positive impact on patient safety, by facilitating uniform training of clinicians using the pumps
and reducing the likelihood of a clinician attempting to use an unfamiliar pump without
training. The introduction of medical equipment ‘libraries’ within many hospitals is a positive
step towards rationalising pumps and also helps to ensure each device is appropriately
managed with regard to battery charging, servicing and other maintenance issues.

In 2003, the MHRA (formerly MDA) published a Device Bulletin relating to the use of infusion
devices. DB2003(02) Infusion Systems [2] can be downloaded from the MHRA website.

ECRI Institute conducted an evaluation of the Hospira Plum A+ pump in 2004 [3]. It was
based on the US version of the device, which differs slightly from the UK model in terms of
software (dose error reduction software is offered on the US pump, but is not yet available on
the UK model). This evaluation can be purchased via the ECRI Institute website.

CEP 07014: 2007

Product description 6

Hospira Plum A+ volumetric infusion pump

The Hospira Plum A+ is designed for both general ward use
and critical care applications. It offers a number of
innovative features, including the facility to deliver two fluids
concurrently down a single line at separate flow rates, and a
novel system for trapping and removing air from the
administration set. Table 1 summarises the main features
of the pump. Refer to Figure 1, Figure 2 and Figure 3 for
labelled photographs of the pump.

Advantages
• Supports concurrent delivery of two drugs at separate rates into a single infusion line
(compatibility of drugs should be checked and guidelines on delivery rates consulted)
• Use of concurrent deliveries could result in cost savings
• Has anti-free-flow protection – a flow regulator in the administration set closes
automatically when the pump door is opened or closed
• Offers direct connection for syringe delivery on all standard sets
• Maintains good delivery accuracy when the fluid container is raised or lowered
• Novel air-in-line detection system traps air and allows direct removal of air from the
administration set without disconnection from patient
• Is relatively easy to use
• Has a large LCD display screen
• Features an integrated confirmation screen prior to starting infusion
• Offers standby settings (infusions programmable for delayed start)
• Includes a drug library for labelling deliveries
• Can be used to deliver blood and blood products
• Design affords easy software upgrades

Disadvantages
• The pump is considered bulky and heavy by some users
• A modular system with a corresponding syringe pump is not available
• Dose limiting software is not yet available in the UK (Hospira plans to introduce this in
2008)
• Inevitable mixing of drugs in secondary fluid container bag occurs when using the
back-prime function. (Hospira comment: This situation will only occur when back-
priming into a secondary IV container. If mixing of drugs is a concern, the clinician
may back-prime into a separate syringe.)
• When there is no roller clamp provided on the administration set, the provided clamp
is difficult to operate with one hand. (Hospira comment: The secondary sets provided
for evaluation contained slide clamps. Hospira has the ability to provide all set
configurations with roller clamps. The white flow regulator in the Plum set may also
be used to control gravity flow rates)

CEP 07014: 2007

Product description 7

Main features
Table 1: Main features of the Hospira Plum A+ volumetric pump

Standard features Standard infusion, rate titration, volume to be infused (VTBI)

Multi-step programming – up to ten sequential steps; each step can be assigned a
different fluid volume and delivery rate
Loading dose – bolus dose followed by maintenance dose
Drug library
Delayed start
Standby mode
Innovative features Concurrent delivery of two fluids in a single line
Syringe delivery by connection to pumping cassette
Air-in-line trap within cassette
Air-in-line removal through port in cassette
Dimensions 20 cm (w) x 20 cm (h) x 15 cm (d)
Weight 4.3 kg
Power supply Mains power: 230 V AC, 50 - 60Hz
Battery: Internal sealed lead acid rechargeable 6V battery
Battery Life: Six hours at up to 125ml/h, or 500 ml at over 125 ml/h on one line
Recharge: Approximately six hours with the device operating at 125 ml/h on one
line
Administration set Only LifeCare Plum Sets can be used with the Plum A+ for the primary infusion line
For the secondary port, a range of standard infusion sets (with luer connection)
can be used
Flow rate range 0.1 – 99.9 ml/h (in 0.1 ml increments) for lines A and B
100 – 999 ml/h (in 1 ml increments) for lines A or B individually
Concurrent delivery: 0.5 ml/hr minimum for each line;
Plumset: 500 ml/h cumulative (A+B) maximum if both lines in use
Pump mechanism Piston Volume Displacement - “Volumetric”
Accessories Syringe adaptor (for use with syringes smaller than 10 ml)
Mini pole (attaches to pump, holds two bags)
Secondary Container Support (can secure a syringe to the cassette door using the
optional support arm)
Tandem carrier (two pumps can be mounted adjacently on a single pole)
Air detection PlumSet (Proximal): Single bubble detection 500 - 1000 μl (non-programmable)
Occlusion detection Distal pressure limit: 52 to 776 mmHg, configurable (default setting is 310 mmHg)
Alarms and alerts Comprehensive alarms: air-in-line, upstream occlusion, downstream occlusion,
depleted battery, low battery, cassette test failure, door open, failed initial safety
check, technical failure, end of infusion, idle two minute alert.
Staff alerting system: nurse call back
Price (ex VAT) £2600
Manufacturer Hospira UK Ltd (Mayne Pharma PLC), Queensway, Royal Leamington Spa,
Warwickshire CV31 3RW
CE marking Yes; 93/42/EEC (Medical Device Directive)
Notified body 0050, National Standards Authority of Ireland, Dublin
Certified to Standard EN/IEC 60601-1-1:2001 ; IEC 60601-1-2:2001-09 Part 1-2; IEC 60601-1-4; IEC
60601-1-8; EN/IEC 60601-2-24

CEP 07014: 2007

Product description 8

Photographs

1. Door lever
2. Door
3. START key
15 4. STOP key
5. AC power indicator
14 6. Power ON/OFF key
7. Numeric field CLEAR key
8. Numeric input keys
9. Decimal point key
13 10. Alarm silence key
11. Navigation keys
1 12. Softkeys – function indicated by
text displayed on-screen
13. LCD screen
2 12 14. Running indicator for Line B
3 11 15. Running indicator for Line A
4 16. Alarm volume control
17. Keypad lockout switch
10 18. Nurse call relay connector
19. Equipotential terminal
9 20. RS-232 interface
5 7 8 21. AC power cord
6
22. Pole clamp assembly

Figure 1. Front of pump

16
17 22
18

19

20
21

Figure 2. Back of pump

Figure 3. Delivery of two fluids

CEP 07014: 2007

Evaluation method 9

A sample of the pump and related consumables were provided by the manufacturer for the
purpose of this evaluation. Information relating to the device’s features, performance,
pricing, training, servicing, reliability and disposal were also provided.

In addition, the device was evaluated through:

• Technical performance testing

• Usability assessment
• A survey of clinical users

Technical testing
Traditionally, a wide range of technical tests has been conducted to verify the accurate
performance of an infusion pump. This evaluation has instead focussed primarily on the
innovative features of the device, and technical testing has been limited to these features.
Tests have been based on the methods laid out in IEC 60601-2-24, with appropriate
modifications to accommodate consideration of the novel features of the pump.

Usability assessment
A usability assessment was conducted by five evaluators who independently assessed the
pump whilst working through a list of typical clinical tasks (derived from consultation with
clinicians, and accommodating the particular features of the device). Findings were noted as
they were encountered. The individual results were then combined into a single list of
positive and negative points. Finally, the negative points were rated in terms of possible
clinical impact.

User survey
Since the pump is new to the UK market, Hospira was asked to provide a list of centres that
had trialled the Plum A+ infusion pump. Questionnaires were sent to users within these
Trusts requesting feedback on their experiences with the pump. Initial pump training had
been provided by the manufacturer. The questionnaire has been used in a wide range of
pump evaluations in the last five years (see Appendix). Follow-up interviews (by telephone
and email) were conducted with several respondents.

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Technical performance 10

Technical tests
1. Concurrent delivery test
The pump was tested to measure delivery accuracy when two fluids are infusing at the same
time. For the entire two-hour test, infusion Line A was set to run at 25 ml/h. After the first
hour, infusion Line B was started at 100 ml/h (concurrently with Line A) for 30 minutes. Table
2 shows the results of this test.

Table 2. Results of concurrent delivery test

Phase Average flow rate (ml/h) Error (%)
Line A only 26.1 +4.4
Lines A and B 123.5 -1.2
Line A only 24.9 -0.2

Delivery accuracy remained within +/-5% of the set rate throughout each phase of the test,
indicating that the pump is able to start and stop a second delivery accurately and that each
drug is delivered at the expected rate. The rate changes were rapid, taking less than one
minute to start and stop the secondary delivery. Figure 4 gives a graphical display of this
result.

Hospira Plum A+
Lines A and B infusing
140.0 concurrently

120.0
Flow rate (ml/h)

100.0

80.0

60.0

40.0 Line A infusing Line A infusing

20.0

0.0
0 60 120
Time (minutes)
Set flow rate =125 ml/h Max. error over any hour =0.00 %

Figure 4. Results of concurrent delivery test

CEP 07014: 2007

Technical performance 11

2. Air-in-line testing
The Hospira Plum A+ features a novel air-detection system. An air ‘trap’ is included in the
cassette part of the administration set, capable of containing approximately 2 ml of air.
Sensors are located to detect air either trapped in the cassette or distal to the pumping
chamber within the cassette. Single bubbles, or an accumulation of air above a threshold,
trigger an alarm and stop the infusion. The trap detects bubbles greater than 0.5 ml for a
proximal air occlusion while the distal alarm detects 0.1 ml bubbles (these figures are flow-
rate dependent and non-configurable).

The pump has a ‘back-prime’ feature that allows the trapped air to be pumped out of the
secondary port in the cassette, either into a fluid bag or syringe. This has a potential clinical
value, in that the air remains trapped and can subsequently be removed from the cassette
through back-priming, without the need to disconnect the line from the patient.

To test the system, small (0.1 ml) air bubbles were sequentially introduced into the
administration set upstream of the pump. The air introduced into the system accumulated
within the air trap of the cassette and remained there without passing through to the distal
part of the set. The alarm sounded when a sufficient volume of air had been introduced into
the system. The alarm was triggered after an average of 1.3 ml had been introduced. In
every test, it was possible to remove all the trapped air by back-priming into a secondary
container.

3. Container height test

Hospira states that delivery accuracy is virtually independent of the fluid container position
relative to the pump; and that any height variations would affect the delivery accuracy by no
more than +/-2%.

To test this claim, the pump was set to run for five hours at a delivery rate of 125 ml/h.
During this time, the fluid container was set first at a normal height (about 30 cm above the
pump), then raised to a high position (about 60 cm above the pump) and then finally lowered
to a position about 25 cm below the pump.

The delivery accuracy remained excellent throughout the test, delivery errors being less than
1% at each bag position, and no relationship was seen between container height and fluid
delivery accuracy.

It is normal for pumps to perform acceptably well in this test. However, the Plum A+
performance is excellent and this may make the pump suitable to applications where
transport is involved and frequent changes to fluid container height may be expected.

However, users should remain aware that abnormal positioning of the fluid bag is not
recommended in clinical practice, and where possible, effort should be made to ensure that
the fluid container is always appropriately positioned (i.e. the drop chamber should be around
30 cm above the pumping mechanism).

CEP 07014: 2007

Technical performance 12

Usability assessment
The laboratory-based usability assessment was conducted by five evaluators who
independently performed a series of clinically typical tasks.

From this assessment, the results demonstrated good overall performance in terms of
usability; the pump and its available features can be considered relatively easy to use. Of
the negative issues identified, five were rated as major, while the great majority were rated
as minor or cosmetic in nature. A number of positive points were also recorded, indicating
instances of good design with respect to usability.

Positive points
• The general operation of the pump was clear and easy
• Air collected in the cassette's air trap can be visually checked
• The pump has an integral power lead
• The instructions on the side of the pump are clear and concise
• The battery indicator on screen is clear and simple
• The carry handle on the pump provides a good secure grip
• The pole clamp has a good large knob
• The keypad is large and uncluttered
• The cassette can only be loaded one way into the pump
• At the end of VTBI, KVO starts appropriately, and then pressing STOP stops this
KVO
• Back-priming was very easy to do; and the cassette test was performed automatically
afterwards by the pump to check that it was ready for pumping
• The drip bag holder is a useful accessory as an easy transport option
• The attached 15-page quick-start guide is well laid out and clear
• The softkey labels appear to be located to prevent programming by repeated presses
of the same key - this change of location of the next step key is good, requiring
continuous engagement during programming
• The ‘Start’ key gives an option to start either one line or both lines, which is useful
• Selected drug names are displayed on screen throughout pumping
• When the pump is first turned on, the option is given to clear the previously used
settings and start afresh
• The rate & VTBI settings can be entered for line A while line B is infusing
• ‘Self test in progress' is a good simple message at start up
• The three quick sounds as a warning that an incorrect value has been entered are
helpful and easily recognisable
• The display screen is large and bright
• It is easy to program the drug calculator and the drug list is extensive
• The icon design is intuitive
• The flash tips booklet is useful and contains an explanation of the pump alarms
• Feedback messages clearly explain what the user needs to do next (e.g. enter value
using keypad)
• Good feedback is provided on button presses. Double auditory "beep, beep" when
buttons are not doing anything and single "beep" when they are. This follows
conventions and was considered intuitive

CEP 07014: 2007

Technical performance 13

• There is good feedback to indicate that a new flow rate will affect the duration of an
infusion
• Good feedback is given upon entering settings for Line A or B. The pump copes well
with the need to start and stop different lines. The user is able to start and stop both
in unison, or separately

Negative issues
Figure 5 shows graphically the proportions of cosmetic, minor and major usability issues
identified.

Cosmetic

Minor

Major

0 10 20 30 40 50 60 70 80
No. of usability issues

Figure 5. Summary of the usability issues identified

The five ‘major’ issues identified were as follows:

• If the pump is stopped, ‘back-prime’ is available as a single key press, allowing the
user to shift fluid from line A to B at an unknown rate. This should not be so easy to
do (Hospira comment: To access the back-prime feature, the device must first be
stopped and on the home screen. To perform the back-prime, the softkey must then
be held down continuously. If the key is not held the device stops back-priming)
• Some mixing of drugs is inevitable in the secondary bag if using back-prime with a
second bag in place (Hospira comment: This situation will only occur when back-
priming into a secondary IV container. If mixing of drugs is a concern, the clinician
may back-prime into a separate syringe)
• With the cassette out of the pump, it is possible to push the contents of the syringe in
channel B into the Line A bag, even though cassette closure screw is closed. While
there is no risk of administration to the patient, this fluid shift was unexpected and
undesirable (Hospira comment: If the proximal clamp is closed, this is not possible.
There is a notice on the device indicating “If Secondary In Use, Close Primary Clamp
Prior To Opening Door.” This caution statement is addressed in our user training
programme)
• Adjusting pressure limit: it is unclear what the maximum or minimum limits are, the
numerical scale may be unfamiliar to users creating uncertainty whether an
appropriate value or even a default value is in operation
• Multi-step programming: when adding more steps and deciding to go back to a
previous step, there are two options: ‘Cancel/Back’ and ‘Prev Steps’ situated next to

CEP 07014: 2007

Technical performance 14

each other. Pressing ‘Cancel/Back’ removes all the programming already done; it is
likely that errors will occur at this stage. Moreover, there is no undo step

The more notable minor points are summarised here:

• The pump is somewhat large and heavy

• The display screen is vertical, making it difficult to read when positioned below eye
level
• To connect a large syringe securely to the secondary port, a special holder is
required to prevent it ‘drooping’ forwards. This is available as an accessory but may
not always be to hand when needed (Note: Hospira has developed a more rigid
secondary port that addresses this issue. A pre-production sample has been seen,
and the product will be available by end of 2007)
• The cassette appears somewhat complex, and loading it correctly could be
problematic for novice users
• The use of a sliding clamp instead of a roller clamp on primary and secondary
administration sets made use more difficult, especially when trying to perform tasks
with one hand only (Hospira comment: The secondary sets provided for evaluation
contained slide clamps. Hospira has the ability to provide all set configurations with
roller clamps. The white flow regulator in the Plum set may also be used to control
gravity flow rates)
• Displaying data for both Lines A and B simultaneously on screen is generally well
achieved, but some instances of confusion were noted
• The screen refreshes slowly and at times becomes asynchronous with programming
key presses
• It was sometimes unclear whether the ‘Clear’ function would clear all settings or just
the parameter highlighted
• To scroll through long lists (such as the drug list) the user has to press keys
repeatedly – an ‘auto-repeat’ feature may facilitate scrolling
• Since both Lines A and B deliver through one infusion line, an alarm that causes the
pump to stop will interrupt both infusions. It is possible that a problem with a
relatively unimportant drug infusion from one line could stop a more critical delivery in
the other

CEP 07014: 2007

Operational considerations 15

Clinical impact
In some clinical settings, multiple drugs will regularly need to be delivered simultaneously. If
the drugs have flow-rate requirements and compatibilities that match the capabilities of the
Plum A+, cost savings associated with using fewer devices and inexpensive secondary
administration sets may be significant.

The facility of delivering a drug from a syringe at a controlled flow rate through the secondary
port may prove useful in several clinical areas. Some chemotherapy drugs in particular are
often delivered manually by syringe. Staffing pressures can make it difficult to adhere to the
correct delivery rate for these manual deliveries and there is an acknowledged tendency to
deliver drugs more rapidly than is recommended. The ability to use a pump to control such
deliveries and ensure they are given correctly may prove useful.

The pump may be suitable in cases where excellent accuracy needs to be maintained
despite a reduced or changing fluid container height. Transport applications (ambulances)
and homecare parenteral nutrition are two examples where this performance feature may be
relevant.

The air-trapping and relatively easy visual inspection and clearance of air from the
administration set may prove beneficial where nuisance air alarms are a known problem. For
example, it is reported that Herceptin has a tendency to ‘froth’ when delivered by volumetric
infusion pumps. This frothing presents a potential hazard to patients and can cause
interruptions to the delivery, potentially leading to drug wastage if the air cannot be cleared
from the line. An effective and simple-to-use air-clearing system, as featured on the Hospira
Plum A+ may be beneficial. Hospira also claims this system results in fewer cases of
administration sets being wasted by avoiding situations where the nurse is unable to clear
trapped air from the infusion line. In the user survey conducted for this evaluation, some
users reported dissatisfaction with the air removal process, due to the potential contact with
toxic drugs – such as some chemotherapy agents. On infusion devices without this back-
prime functionality, however, clinicians need to disconnect the line and purge air manually.
This process also exposes clinicians and patients to the chemotherapy agent. Back-priming
is, in essence, a closed process not requiring disconnection. Hospira states that, after back-
priming, the syringe or secondary set may be left attached to the cassette for later use and
the clinician may resume the infusion. These issues highlight the importance of appropriate
training in use of the novel back-prime feature.

The pump has been tested (not as part of this evaluation), and is capable of delivering blood
and blood products without causing detectable cellular damage to the blood (data supplied
by Hospira) [4].

The pump does not currently offer dose-limiting software or advanced software for integration
with hospital information systems. However, these features have been successfully
launched in the USA, and it can be expected that they will be released in the UK in 2008.
The hardware design of the pump should allow a relatively easy upgrade to installed pumps
through a simple electronic card change.

CEP 07014: 2007

Operational considerations 16

Some users commented on the pump being large or bulky, which is potentially a problem if a
large number of pumps need to fit into a confined space. Hospira offers a tandem carrier to
allow two pumps to be supported side by side on a pole.

User experience
A user survey was conducted to seek the opinions of clinicians who had trialled the pump.
Some had used the pump for two weeks, while others had used it for more than three
months. It was found that data collected from the surveys were not adequately comparable
for inclusion in this evaluation. Instead, the trial sites have been considered as ‘case
studies’, and additional interviews have been conducted to elicit responses from a number of
clinicians at these sites.

Case one
The Hospira Plum A+ infusion pump was used daily for a two-week trial in an
Oncology/Haematology unit. A manufacturer’s representative was present for the first week
of the trial to help with any difficulties. Most infusions were used to deliver chemotherapy
agents, including Epirubicin, Cyclophosphamide, 5-Fu, Doxorubicin, Vincristine, Vinblastine,
Mitoxantrone, Bloemycin, Rituximab, Zomita and Pamidronate.

Strengths:
• Staff found the instructions for setting up and operating the pump easy to follow
• 75% of staff found the pump “useful”; while others thought the pump kept them away
from the patients
• There were no reliability problems with the trial pumps
• One respondent felt confident that the pump would do what had been programmed
whilst he was attending to other patients
• The concurrent delivery of two fluids was considered a very useful feature because
pressure on the vein could be controlled
• One respondent felt that resolving air-in-line alarms was the best feature on any
pump he had used – being very easy to operate. Back-priming was considered easy,
and it prevented most of the complications experienced with other pumps
• No problems were reported to cause concern

Case two
Responses were received from five nurses following a two-week trial in a Chemotherapy
Suite. These have been combined to generate a list of positive and negative comments:

Strengths:
• The display is clear
• The administration set is easy to insert
• Allows two compatible medications to be delivered at once

Limitations:
• Some drug spillage occurred when removing the syringe from the secondary port
after back priming to clear air. This was particularly undesirable as it involved
CEP 07014: 2007
Operational considerations 17

cytotoxic drugs, and it led to apprehension about the air removal facility. It was felt
that it would be difficult to remove air from the line without contamination of line or
staff. (Note: The instruction manual advises “Before disconnecting a syringe from the
cassette, pull up the plunger slightly to avoid spilling the fluid”. While this was found to
work adequately in the laboratory, it highlights the need for full training with careful
regard to particular clinical needs. This issue is discussed on p.14)
• Entering infusion rate, volume and time was slow compared to other pumps
• There was no roller clamp on the set tubing (Hospira comment: The secondary sets
provided for evaluation contained slide clamps. Hospira has the ability to provide all
set configurations with roller clamps. The white flow regulator in the Plum set may
also be used to control gravity flow rates)
• Text on the pump is too small to read
• The pump is noisy when infusing
• The pumps are bulky when two of them are side by side and the pole bracket was
awkward to use
• Alarms are not loud enough if used in ward areas
• Alarms are confusing – it is not always easy to address the issue
• Screen is too busy, with too many options on display; this can be confusing,
particularly when differentiating channels A and B

CEP 07014: 2007

Operational considerations 18

Consumables
There is a variety of infusion sets available for the Plum A+ pump, as shown in Table 3.
Note: all sets are latex-free.

Table 3. List of consumables with their list price* for the Plum A+ infusion pump
Price for a
Code Description List Price
box of 50
F825 LC Plum IV Pump Set £4.95 £247.50
F056 LC Plum Secondary IV Pump Set £1.60 £ 80.00
F821 LC Plum Y Type Blood Pump Set £8.95 £447.50
G626 LC Plum Syringe Microbore Pump Set £5.50 £275.00
11003 LC Plum IV Fat Emulsion Pump Set £7.95 £397.50
L218 LC Nitro Pump Set £8.95 £447.50
F826 LC Plum Soluset 150x60 Pump Set £8.95 £447.50
LC Plum 0.2micron Clave Adapter Pumpset Photo-
P317 £9.95 £497.50
protective
L417 LC Plum Luer-Lock Proximal End £7.95 £397.50
P285 LC Plum Standard Set with Clave Adapter £9.50 £475.00
M405 LC Plum Set with Pre-pierced Reseal Assembly £9.50 £475.00
P741A52 IV Dual Channel Infuser Set: no distal injection site £4.95 £247.50
*Note: Significant discounts on list prices may be available

Service requirements
Hospira offer an annual service contract at a cost of £100 per pump purchased. The
agreement includes one full service per year for each pump, return-to-base breakdown cover
(facility is ISO EN 13485 registered), loan devices available within 24 hours on request, a
collect-and-deliver service on all repairs, and detailed repair reports. The average
turnaround time is nine days.

The standard warranty period is one year. While under this warranty agreement, problems
with the pump may be resolved by repair or replacement at the discretion of Hospira. There
is an option to extend this warranty for a further five years at an additional cost. The
replaceable battery is treated separately and is guaranteed against defects in material and
workmanship for a period of 90 days of normal use after purchase.

CEP 07014: 2007

Operational considerations 19

Maintenance
The service contract covers maintenance and repair issues. To report problems to the
manufacturer, there is a 24-hour helpline that is open 7 days a week. If a pump is returned
to base for repair, a replacement can be issued on loan within 24 hours. There is a spare
parts supply service that ships from stock on the next day. Also included in this contract is
an annual service check on all pumps purchased and a device analysing service, if required.

A field- or factory-based preventative maintenance inspection service is available. If field

maintenance is required, a technician can be on site within 48 hours. The option is also
available for the local equipment management service to be used to handle minor repairs or
changes of battery, and this does not invalidate the Hospira warranty agreement.

Data from the USA, where the Plum A+ system is well established, gives mean time to first
failure (MTTFF) of 6.5 years for the pump. The pump’s expected lifetime (estimated by
Hospira) is 10-15 years.

CEP 07014: 2007

Economic considerations 20

Calculation of whole-life costs

The calculation of whole-life costs is based on usage data (for a different volumetric pump)
within a District General Hospital. Data for the Plum A+ system itself is not available, since
the pump is relatively new to the UK market.

For comparability, list prices (ex. VAT) have been used for the pump and consumables.
Significant discounts on these prices may be available from the manufacturer, and up-to-date
quotations should be sought when making comparisons. Service and maintenance costs are
included, and a working life of 10 years has been assumed, in line with manufacturer
recommendations. Training is currently offered by the manufacturer at no additional cost.
Table 4 shows the calculation of costs based on a one-off purchase of 200 pumps to meet
the needs of the Trust.

Table 4. Cost calculation - 200 pumps in use for 10 years

Description Quantity List price* (£ ex. VAT) Total (£)

Plum A+ pumps 200 2600 520,000
Standard sets 31,300 per year 4.95 1,549,350
Blood sets 1,700 per year 8.95 152,150
Service contract 200 per year 100 200,000
Cost to Trust over 10 years: 2,421,500
Annual cost per pump: 1,211
Note: Significant discounts on list prices may be available

Hospira claims that use of the Plum A+ in a typical range of clinical settings would allow a
proportion of infusions to be given concurrently, leading to a reduced demand for pumps and
also some use of inexpensive secondary sets in place of primary sets. The manufacturer
suggests a possible 20% reduction in the number of pumps required, and a 20% reduction in
the use of primary administration sets (with a corresponding increase in the use of secondary
sets). Applying these proposed figures, the cost calculation is as shown in Table 5.

CEP 07014: 2007

Economic considerations 21

Table 5. Cost calculation - 160 pumps in use for 10 years

Description Quantity List price* (£ ex. VAT) Total (£)
Plum A+ pumps 160 2600 416,000
Standard sets 25,040 per year 4.95 1,239,480
Secondary sets 6,260 per year 1.60 100,160
Blood sets 1,700 per year 8.95 152,150
Service contract 160 per year 100 160,000
Cost to Trust over 10 years: 2,067,790
Annual cost per pump: 1292
*Note: Significant discounts on list prices may be available

This calculation indicates a significant saving to the Trust (£353,710 saved over 10 years).

The calculations shown here are indicative only and it is recommended that relevant local
data should be applied when making cost calculations. The requirement for devices,
consumables and servicing arrangements will vary substantially between Trusts. This is the
first infusion device evaluation report to include whole-life cost calculations and direct
comparison with other devices is therefore not possible at this stage.

CEP 07014: 2007

Purchasing 22

Determining the clinical requirements

When purchasing new infusion pumps, a range of people, including clinicians and equipment
managers, should be consulted to specify the requirements for devices. The tender exercise
may extend beyond an individual Trust into a regional procurement exercise, and this may be
co-ordinated by a Collaborative Procurement Hub (CPH).

Existing evaluation reports may assist the process of short-listing and device selection.
MHRA and CEP evaluation reports published since 2002 can be downloaded from the NHS
PASA website. MHRA device bulletin DB2003(02) Infusion Systems [2] is also of use in the
process.

A trial of short-listed devices is recommended to verify that they adequately meet local
needs.

If concurrent delivery, syringe delivery and/or an effective means of trapping and removing
air from the line are considered valuable features in a particular setting, the Hospira Plum A+
pump may offer some advantages.

Drafting a business case

It is recommended that whole-life cost calculations are used when drafting a business case,
using realistic prices for pumps and consumables (if these can be obtained from pump
suppliers). Local information should be used to estimate usage requirements (pumps and
consumables), and servicing and maintenance arrangements.

Sustainable procurement
The estimated lifetime of the pump is 10-15 years. This is typical for modern infusion
technology and is considered a satisfactory lifespan. An MTTFF of 6.5 years, based on
extensive reliability data from the USA market, indicates that this lifespan is a realistic
estimate.

The novel feature of concurrent delivery and direct connection of syringes as a container for
secondary infusions present possible savings both in the number of devices required within a
given clinical setting and in the number of relatively complex primary administration sets
required. The figures laid out in the economic considerations section of this report can be
translated to give some measure of the reduced environmental impact associated with this
feature. Hospira estimates savings of up to 20% both in the number of pumps purchased
and in the number of primary administration sets required.

Hospira states that Plum A+ is supplied in 100% recyclable packaging. When the pumps are
taken out of use, all possible parts are reused and non-reusable parts are sent for recycling
by an approved national contractor.

CEP 07014: 2007

Conclusions 23

Conclusions
The Hospira Plum A+ has performed well in evaluation, showing both accurate technical
performance and good usability, with clear displays and logical programming steps.

Its abilities to deliver two fluids simultaneously through a single line and to deliver drugs from
syringes may offer practical advantages in some clinical settings and may lead to potential
cost savings.

Facilities for safely trapping and removing air-in-line are effective and useful. The ability to
deliver fluid accurately despite changes in fluid container height may also be advantageous
in some settings.

The pump does not yet offer advanced dose limiting software, but this is offered on the same
device in the USA and it is expected to be introduced in the UK in 2008. The pump is
designed to allow relatively easy upgrades of this nature through a simple card change.

CEP 07014: 2007

References 24

1. IEC 60601-2-24 (1998) Particular requirements for the safety of infusion pumps and
controllers.

2. MDA DB 2003(02) Infusion Systems, March 2003.

3. ECRI report: Health Device 33 (12) p417-426 , December 2004.

4. Abbott Electromechanical Infusion Devices Red Cell Study by Toby L. Simon,

Transfusion Research Laboratory, University of New Mexico School of Medicine,
November 1990.

CEP 07014: 2007

Appendix 25

Questionnaire
Please complete the attached questionnaire without conferring with colleagues. The results
should represent your own opinion. All assessors’ identities are confidential and are not used
in the evaluation report. We may need to contact you to clarify your responses, and have
requested some personal details in order to balance the survey population. If you have any
queries about the questionnaire, please contact BIME on 01225 465615 or email:
pumpeval@bath.ac.uk.

Please return this form to . The results of this survey will be used as the
basis of a “user assessment”, forming part of a Centre of Evidence Purchasing (CEP) NHS
evaluation of the Hospira Plum A+ infusion pump.

Thank you in advance for your assistance.

Assessor Information
User Name

Date of birth

Gender (circle as Male Female

appropriate)
Handedness (circle as Right Handed Left Handed
appropriate)
Clinical Specialty
Number of months using How frequently do
the pump? you use this pump
weekly?
The questionnaire is divided up into sections covering different infusion processes. All
questions require evaluation on a scale of 1 to 5 where:

5 Very good, could not realistically be any better

4 Good but could be improved
3 Adequate
2 Less than adequate but could be worse
1 Extremely poor

CEP 07014: 2007

Appendix 26

There is also space for additional comments. These are often the most valuable source of
information from the assessment so please take the time to add any comments that occur to
you.

Product Training
Was specific training received for this device: Yes/No. If No go to question 2.

V. Good Good Adequate Inadequate Poor

1. The specific training for this No
5 4 3 2 1
device was: comment

Additional comments:

Training was supplied by: Please tick as many boxes as apply

a) manufacturer
b) tuition by a previously trained colleague
c) tuition by a Trust-based trainer
d) other

User Instructions V. Good Good Adequate Inadequate Poor

2a. The overall quality of the
No
user instructions for this 5 4 3 2 1
comment
device was:

Additional comments:

2b. How would you assess

No
the readability of the 5 4 3 2 1
comment
manual(s):
Additional comments:
2c. The coverage of the No
5 4 3 2 1
instructions was: comment
Additional comments:
2d. The user instructions on
No
the body of infusion pump 5 4 3 2 1
comment
were:
Additional comments:

Appropriateness of Device V. Good Good Adequate Inadequate Poor

3a. The device’s suitability for No
5 4 3 2 1
your application was: comment

Additional comments:

CEP 07014: 2007

Appendix 27

No
3b. The battery life was: 5 4 3 2 1
comment

Additional comments:

No
3c. The size of the pump was: 5 4 3 2 1
comment
Additional comments:
3d. The weight of the pump No
5 4 3 2 1
was: comment
Additional comments:
3e. The ease of moving pump
No
when disconnected from 5 4 3 2 1
comment
patient and stand was:
Additional comments:
3f. The robustness of the No
5 4 3 2 1
pump was: comment
Additional comments:
No
3g. The pole clamp was: 5 4 3 2 1
comment
Additional comments:

Administration Set V. Good Good Adequate Inadequate Poor

4a. The suitability of the
No
supplied administration 5 4 3 2 1
comment
set was:
Additional comments:

Loading the Set V.Good Good Adequate Inadequate Poor

5a. The loading procedure for No
5 4 3 2 1
the set/syringe was: comment
Additional comments:
5b. The priming procedure for No
5 4 3 2 1
the set/syringe was: comment
Additional comments:
5c. The ease of setting
No
syringe brand and size 5 4 3 2 1
comment
was: (syringe pump only)
Additional comments:

Setting parameters and

V.Good Good Adequate Inadequate Poor
Starting Infusion
6a. The ease of setting the No
5 4 3 2 1
rate was: comment

CEP 07014: 2007

Appendix 28

Additional comments:
6b. The ease of setting the No
5 4 3 2 1
VTBI was: comment
Additional comments:
6c. The ease of navigating the No
5 4 3 2 1
control panels was: comment
Additional comments:
No
6d. The visual displays were: 5 4 3 2 1
comment
Additional comments:
6e. The clarity of messages No
5 4 3 2 1
were: comment
Additional comments:

Monitoring the Infusion V.Good Good Adequate Inadequate Poor

7a. The noise level whilst No
5 4 3 2 1
running was: comment
Additional comments:
7.b. The running indicator No
5 4 3 2 1
clarity was: comment
Additional comments:
7c. The display of rate/VTBI No
5 4 3 2 1
during an infusion was: comment
Additional comments:
7d. The alarm messages No
5 4 3 2 1
were: comment
Additional comments:
No
7e. The alarm tone was: 5 4 3 2 1
comment
Additional comments:
7f. The appropriateness of No
5 4 3 2 1
alarms were: comment
Additional comments:
7g. The safeguards against No
5 4 3 2 1
tampering were: comment

Additional comments:

Infusion Complete V.Good Good Adequate Inadequate Poor

No
8a. The ease of cleaning was: 5 4 3 2 1
comment
Additional comments:

CEP 07014: 2007

Appendix 29

8b. The ease of charging was: 5 4 3 2 1 No comment

Additional comments:

General Questions

9a. List any features that you would like to see which are not present on this pump:

9b. List any features that are present but which are unsuitable for your application:

9c. Are there any additional comments that you would like to make on your experience of using this pump?

CEP 07014: 2007

Appendix 30

Laboratory-based usability assessment protocol

Instructions
Before starting the tasks, read the appropriate sections of the instruction manual. If tasks are
unclear, ask for clarification of the meaning of the task (however, the method of actually
carrying out the task will not be discussed). Make note of any usability problems that you
discover whilst performing the tasks.

Mount the pump on a pole, prime a set with fluid using the manufacturer’s recommended
technique.

• Set up an infusion to run at 100 ml/h. Start the infusion and check it is running properly
• After the infusion has delivered 2 ml, change the rate to 20ml/h and, if necessary, restart
the pump
• Start an infusion at the maximum rate, with VTBI of 50 ml. After the infusion has stopped
observe whether KVO rate is operating
• Stop the pump and ensure delivery to patient has stopped
• Start an infusion at 250 ml/h, and, at some point, introduce an air bubble to the system by
inverting the bag for 10 seconds and allowing air from the bag to be drawn into the
delivery line through the drip chamber. Re-hang the bag and wait for the air alarm.
Resolve the problem by back priming into a syringe. Resume the infusion
• Set up a secondary line. Set up the following infusion and prepare both lines on standby:
Line A: drug label: lipids, dose calculation, mg/kg/hr, 100mg in 1 ml, 100kg patient, 60
mg/kg/hr, VTBI 2ml, prog options standby
Line B: drug label antibiotics, dose calculation, ml/hr, 20 ml/hr VTBI 1ml CONCURRENT,
prog options standby
• Start both lines simultaneously if you can and let them both run to completion. When
both have reached KVO, stop both lines
• Adjust the occlusion pressure to its minimum level (and record this) and make the pump
as loud as possible and the display as bright as possible, then go back to the original
settings
• Explore the pump and its functionality, covering issues relating to general handling, pole
clamping, power supply, button pressing, display clarity and readability, button labelling
air-in-line and other alarms, available infusion options and so on

Severity ratings
Each evaluator rates each identified problem for severity on the following scale

0. Not a usability problem

1. Cosmetic problem only
2. Minor usability problem
3. Major usability problem
4. Usability catastrophe

To rate the problem, evaluators should consider the following factors

CEP 07014: 2007

Appendix 31

• Potential impact on patient safety

• Impact on clinician’s experience
• Likelihood of occurrence
• Whether the problem will only affect inexperienced users

Problems that could directly lead to patient harm should be given high severity ratings,
particularly if they appear likely to occur in clinical use.

Finally, the five severity ratings for each usability problem were averaged to give an overall
severity assessment for that problem.

Glossary
Back-prime Removal of air or fluid from the proximal tubing and cassette air trap by rapid
pumping of fluid from Line A to an output receptacle on Line B. No fluid is
delivered distal to the cassette during a back-prime*.

KVO Keep Vein Open. Minimal delivery rate at the end of delivery to allow
sufficient fluid flow to prevent clotting occurring at the IV infusion site.

VTBI Volume To Be Infused. The volume of fluid or IV solution remaining to be

delivered by a programmed delivery.*

*
Definition taken from user manual for Hospira Plum A+ infusion pump.
CEP 07014: 2007
Author and report information 32

Hospira Plum A+ volumetric Sign up to our email alert

infusion pump service
Jennifer Chan and Craig Davey All our publications since 2002 are
available in full colour to download from
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www.bime.org.uk Tel: 020 7972 6080
Fax: 020 7975 5795
About CEP Email: cep@pasa.nhs.uk
www.pasa.nhs.uk/cep
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Purchasing (CEP) is part of the Policy and © Crown Copyright 2007
Innovation Directorate of the NHS
Purchasing and Supply Agency. We
underpin purchasing decisions by
providing objective evidence to support the
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We are here to help you make informed

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CEP 07014: 2007