Robert Smith Sr. Director, Quality Medication Delivery Baxter ...

September 28, 2005
Baxter Heahhcare Corporation
Route 120 and Wilson Road
Round Lake, IMinois 60073
847.546.6311
COLLEAGUE Volumetric Infusion Pump Battery Notification
February 25, 2005
Dear Biomedical Engineer:
During a review of our records, it was noticed that your facility has received a COLLEAGUE
Volumetric Infusion Pump(s) after the attached February 25, 2005 notification was sent to
customers.
Please review and respond to the attached letter following the instructions provided. We
apologize for any inconvenience this delay in mailing may have caused you or your staff. If you
have any further questions, please contact Baxter Medication Delivery Services at
1-800- THE-PUMP (1-800-843-7867).
Sincerely I
Robert Smith
Sr. Director, Quality
Medication Delivery
Baxter Healthcare Corporation
cc: Director of Nursing
COLLEAGUE and Baxter are registered trademarlcs of Baxter International, Inc.

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COLLEAGUE VOLUMETRIC INFUSION PUMP (Battery)
Customer Reply Form
(Important Product Information Letter Dated February 25, 2005)
Facility Name and
Address:
Reply Confirmation !
Completed By:
(Please print name)
Title:
(Please o!i!!!L
Telephone Number
(including Area Code)
We understand the contents of the letter and have disseminated this information to our
staff and to other services, facilities, or home patients, as applicable.
Signature/Date:
(REQUIRED FIELD)
To order the battery harnesses with protection circuit: Please complete additional
information below
Please send battery harnesses with protection circuit (part number BHRNSKlT) for the number of I
infusion pumps listed below:
2M8151 COLLEAGUE Single Channel Infusion Pump
2M8153 COLLEAGUE 3 Channel Infusion Pump
2M8161 COLLEAGUE CX Single Channel Infusion Pump
2M8163 COLLEAGUE CX 3 Channel Infusion Pump
COLLEAGUE and Baxter are registered trademarlcs of Baxter International, Inc. 2005-011 MD.

Baxter
February 25, 2005
BaXlet'H88IIM:8reCorporalkxl
RCXII8 120 & WIIIon ~
Rcx.Id L-.. I~ a73-O49O
847.546.6311
Re: COLLEAGUE VOLUMETRIC INFUSION PUMP, PRODUCT CODES
2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, 2M8163R
Dear Biomedical Engineer'
Baxter Healthcare Corporation is sending you this letter to provide you with important
supplemental infonnation to the letter dated January 21, 2003, regarding sealed lead-acid
batteries used in the COLLEAGUE family of infusion pumps. Key points from this information are
provided below. An Operator's Manual Addendum is enclosed and should be distributed within
your facility. as appropriate.
BatteN Service Life. Reolacement and Pumo StoraCE
. A lead-acid battery has 68 or more full discharge/recharge cycles during its service life.
In the Operator's Manual Addendum are recommendations for optimizing the battery
service life.
. The more often a battery is cycled, the. sooner it will require replacement.
. Always replace both batteries at the same time, with two new batteries.
. Never store the pump unplugged and powered on. The batteries may discharge
completely, resulting in permanent damage. For pump and battery storage
recommendations, please see the enclosed Operator's Manual Addendum.
Swollen Batterv
. At the end of a battery's life, swelling can occur. While we have not received any reports
of adverse events related to the swelling of batteries, the pump case can become hot to
the touch and internal pump damage can occur.
. Swelling can be prevented if both batteries are replaced before the end of their useful
lives and can be postponed by good battery charging and pump usage patterns.
. COLLEAGUE pumps listed on the table below have been manufactured with an
overcurrent protection circuit in the battery harness. This overcurrent protection circuit
provides integral fuses and diodes to help protect the batteries from overcurrent damage
and swelling during charging.
COLLEAGUE Bnd Baxter we registered trademarlcs of &xter IntemationBl, Inc. 2005-011 MD.

In February 2005, we implemented replacing the battery harness in our Repair Service
Depot operations. Any pumps that require battery replacement will receive the battery
harness with overcurrent protedion circuit as they are processed through our service
centers.
We encourage your institution to install the battery harness during routine battery
replacement or as part of the device's recommended annual preventative cycle. The
battery harness with the overcurrent protedion circuit will be provided at no additional
charge. Please follow the instructions on the reply form to place an order for the harness.
Initially, we will have a limited number of battery harnesses with overcurrent protection
circuit, and circumstances may require us to partially fill your order.
Excessive Discharoe
. Damaging discharges may occur when the pump is left on battery power for an extended
period of time after the 'Battery Depleted' alarm occurs.
. When batteries become damaged due to excessive discharge, the battery indicator will
overstate the amount of charge remaining.
. As a reminder, you must connect the pump to AC power when the Battery Low Alert
occurs. While in Battery Alert, a properly maintained battery will provide approximately
30 minutes of infusion time left.
. Damaged batteries do not impact the pump's ability to function properly while on AC
power, provided that no other failures or alarm conditions are present.
. During preventive maintenance, it is important to look in the Battery and Pump History
service screen to identify the number of discharges below the alarm threshold. If more
than one excessive discharge is listed in the battery history log, we recommend testing or
replacing both batteries. Specifics conceming preventative maintenance and battery test
linstallation instructions are listed in the product Service Manual.
. Future software updates will address the issue of battery damage due to excessive
discharge. You will be notified when the software is available.
Please complete the attached reply fonn, confinning your receipt of this letter, and fax it back to
Baxter using the number provided. To order battery harnesses with protection circuit, please
complete the additional infonnation requested on the reply fonn.
If you have questions concerning this communication, please contact Baxter Medication Delivery
Services at 1-800- THE-PUMP (1-800-843-7867). If you have provided COLLEAGUE devices to
other services, facilities, or home patients, please forward this infonnation as appropriate. The
Food and Drug Administration has been advised of this communication.
We appreciate your time and attention to this communication.
Sincere~~
-al~
Vice President, Quality
Baxter Healthcare Corporation
Medication Delivery Division
Enclosure: COLLEAGUE Operator's Manual Addendum
COLLEAGUE and Baxter are registered trademarlcs of Baxter International, Inc. 2005-011 MD.

Baxter
Authorized Representative:
I.A.
B- 7860 Less/nes
... Hnlthc-. c.,..ti8n
Deerfield,lL 60015 USA
Q CopyrVlt 2003 Baxter HealtlXa'e Corporation. AllII;a ~
Baxter am ca~ are trDmarks 01 Baxter IIB1BIiM8III1:.
Please read this addendum!
. It applies to all Colleague pumps, all Colleague 3
pumps, all Colleague CX pumps, and all Colleague 3 CX
pumps.
. It provides important information added since your
Operator's Manual was printed about maintaining and
caring for the batteries in y?ur Colleague Pump.
. It is a part of your Colleague Pump Operator's Manual.
Keep it with your Operator's Manual. Your manual is
incomplete without this addendum.
. It supersedes Chapter 7 of the Operator's Manual you
received with your pump.
IIIII III 1111 IIII!IIII II
*O719A4083%*
Revision A
January 2003

*
This manual was printed on paper stock containing a percentage of recycled fiber.

Cleaning Overview
Recommended Cleaners
The exterior of the pump may be cleaned with a soft cloth, sparingly
dampened with any of the cleaners listed below. Do not spray cleaners
djrectly into the tubing channel or the area where the power cord
enters the pump. Do not use hard instruments for cleaning. Follow
the manufacturer's dilution instructions for concentrated cleaners.
Always clean/disinfect the pump after each use. For a pump that has
been in an Isolation Area. select those agents from the list below mat
both clean and disinfect
The pump's design safeguar~ against fluid spillage into the pump
module. Contoct your Baxter Service Center for assistance immediately
if fluid enters the tubing channel. The tubing channel should be cleaned
as soon as possible by authorized service personnel to minimize
potential difficulties caused by fluid pooling and drying on the
mechanism. See "Authorized Service Centers," 10-2.
The following cleaners were tested on the pump:
. Soapy water
. A solution of 10% bleach and water
. Isopropyl alcohol up to 95%
. LpH, by Steris Corporation
. Cidex 7, by Johnson & Johnson
. Super Edisonite, by Brand GmbH
. TOR, Hi-Tor Plus, Huntington Professional Products
. Bafix, Hysan Corporation
07-19-.44-083 COLlEAGUE ~lUMETRIC INFUSION PUMP OPERATOR'S MANUAl ADDENDUM 7-1

7
Preventive Maintenance
Preventi ve Maintenance
Do not clean, disinfect, or sterilize any part of the pump by autoclaving or with
ethylene oxide gas. Doing so may damage the pump and void the warranty.
Only external parts of the pump should be disinfected.
Do not use the following chemicals on the pump, as they will damage the front
panel: acetone, acetoaldehyde, ammonia, benzene, hydroxy toluene, methylene
chloride, and ozone. Do not use cleaners containing n-alkyl dimethyl
ethyl benzyl ammonium chloride unless they appear in the list of recommended
cleaners above.
The table below contains a schedule of basic maintenance tasks that
should be performed on the pump. If the pump cannot be cleaned using
the basic methods described earlier or components are missing or
damaged, discontinue use and notify the appropriate authorized service
personnel. To contact Baxter for authorized service or repair, see
"Service lnfonnation," 10.2.
07-19-A4-GS3

Maintenance and Storage Battery Care Infonnation
Battery Care Information
Battery Service Life
The pump can be battery-powered in emergency situations and while
transporting patients. When battery-powered, the Battery icon ~ lit. To
check the charge level of the batteries, access the Battery OIarge Level
d~play via the Options Menu. See "OIecking Baltery Charge Level,"
4-5 for details.
The following infonnal.ion is intended to assist in optimizing the
perfOl"Dlance and service life of the Colleague infusion pump's primary
batteries. Routine battery care enhances battery perfonnance, which
helps ensure optimal PJmp performance.
Service life is the time a battery can be dischalged and recharged to
useful capocity. While lead-acid baneries are rechargeable, in the course
of use they gradually lose the chemical electrolytes needed to recharge
them to useful capacity. When a battery reoches the point in its service
life where it is DO longer capable of being recharged to a level adequate
to operate the devjce, it must be replaced.
Factors that most commonly affect battery life are as follows
. Frequency of dischaJge/recharge
A lead-acid battery has 68 or more full discharge/recharge cycles
during its service life. The more often a battery is cycled, die
sooner it requircs replacement.
. Depth of discharge
The more often a lead-acid battery is discharged to a low battery
or deep discharge state, the sooner it requires replacement.
. Leaving batteries in a discharged condition
If a battery is less than fully charged, and dIe pump is not
connected to AC power, battery damage can oa:ur within hours.
In a less dIan fuUy charged state, the battery undergoes chemical
changes that produce sulfate and lead precipitate. These chemical
changes severely redoce the battery recharge capability.

7 Battery Care Information
Optimizing Battery Service Life
Battery Preventive Maintenance Program
Charging the Batteries
-
Ensuring the following procedures are a part of routine device use can
optimize battery service life:
. Connect pumps to AC power at all times except in the event of
AC power loss or short-term portable operation.
. Store pumps plugged in to AC power to maintain the battery
charge whenever possible. See the Storage Temperature table in
dtis chapter for information on the effects of temperature on the
b"attery storage time.
. Notify Central Supply or other appropriate departments as soon as
a pump is removed from patient use so that it can be cleaned and
the batteries can be recharged.
. Recharge a pump that is in the Battery Low alert condition for a
minimum of 12 uninterrupted lK>urs.
The most reliable way to check the condition (capacity) of the pump's
batteries at any time during their life is to measure discharge time. The
batteries should provide an operating ti~ of no less dIaD 25 hours
(Colleague pump) or 2 hours (Colleague 3 pump) from fully charged to
Battery Depleted alarm wIY:n all channels infuse at 100 mI.Jbr on
battery power. This test is described in the Colleague Pump Global
Service Manual. Battery packs that do not pass the test are at the end of
their service life and must be replaced. Implementing a program to
replace the batteries prior to the projected end of their service life can
reduce battery problems.
For OOditional infomJation about Iead-ocid battery use in Baxter infusion
devices, contact Baxter Medication Delivery Services at
1-800- THE-PUMP.
The batteries are charging whenever the pump is plugged into a 100-120
VAc. 5

Disposing of Used Batteries
Storage
Storage
In general, the more often the batteries are discharged and recharged, the
sooner they will need to be replaced. Batteries should only t>e replaced
by Baxter authorized service personnel. Always replace both
batteries at the same time, with two new batteries manufactured
within three montllS of one another.
Call your authorized Baxter Service Center (see "Warranty and Service
Information," 10-1) to obtain replacement batteries (Baxter part number
500948(XX) 1).
The pump's sealed lead acid batteries should not be disposed of in the
trash. They may be disposed of in accordance with local regulations or
returned to your authorized Baxter Service Center marked "FOR
DISPOSAL."
Never store the pump unplugged and powered on. The batteries may
discharge completely, permanently damaging them.
Store the pump under the following conditions to maximize banery life.
. Store the pump with its power cord plugged into an AC outlet to
maintain the batteries at full charge whenever possible. Doing so
will maintain the batteries at full charge.
. Ideal storage temperature is noffilal room ambient conditions, at
300 C (860 F) or lower. Storing the pump at higher temperatures
will not damage the batteries as long as the pump is plugged in
during storage or the batteries are fully recharged at the intervals
shown in the table below.
. Never store the pump with the ON/OFF CHARGE key ON and the
pump unplugged. The batteries may discharge completely,
permanently damaging them.
. If pumps must be stored unplugged, fully recharge their batteries
at the intervals shown in the first row of the table below,
according to the temperature of the storage area.
. Recharge spare batteries or batteries removed from pumps at the
intervals shown in the bottom row of the table, according to the
temperature of the storage area.
7-5

7
Storage
. Storing pumps at temperatiJres greater than 30° C (86° F) without
recharging the batteries at the intervals shown in the table will
hasten battery discharge, which may shorten the batteries' overall
operating life.
. Pumps or batteries stored at temperatures below freezing
(0° C or 32° F) must be warmed to room temperature before using
the pump.
. When unpackaged, ensure the pump is stored in a clean and dry
(20-95% RH, non-condensing) environment to safeguard against
prolonged exposure to dust and moisture. In conditions falling
outside the Environmental Operating Limits (see "Technical
Specifications," 8-1), Baxter recommends that the pump be
repackaged in the original shipping materials.
7-6 COLLEAGUE VOLUMETRIC INFUSION PUMP OPERATOR'S MANUAl ADDENDUM
07-19-A4-083