May 14, 2002

Item: Baxter Colleague infusion pumps, product codes 2M8151, 2M8151R,
2M8153, 2M8153R. All units may be affected.

Specific Incident: If fluid enters the pump body (usually during
cleaning), there is a risk of a short circuit later causing the pump to
rapidly cycle on and off. This can happen without any alarms; if this
happens during use, therapy delivery may be interrupted.

Action: 1. If you have not already received and responded to this
notice, immediately (within 24 hours) identify all units affected by
this alert and contact Baxter at 1-800-843-7867, select 2 (for Technical
Assistance) then 1 (for Colleague) to either arrange modification or
obtain the insulators for installation by Biomedical Engineering.

2.  If a pump is exposed to excessive fluids or starts cycling on and
    off, remove it and contact Biomedical Engineering to arrange for
    service.

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3.  Copy, post and follow Baxter's recommended cleaning procedures (see
    attached letter).

4.  As recommended by the manufacturer's letter use the panel lockout
    feature during infusions as standard procedure. This disables the
    on-off switch, preventing the potential on-off cycling and allows
    uninterrupted therapy. Panel lockout is engaged and disengaged by
    pressing the black lockout button on the back of the pump. Remember
    to disengage panel lockout to change pump settings.

Additional Information: Baxter sent letters with fax back response forms
to affected customers on January 11, 2002 (copy attached). Please
contact CEOSH if you are affected and did not receive this letter.

Source: CEOSH, Manufacturer and ECRI

Contact: Baxter Healthcare at (1-800-843-7867, then press 2 (for
Technical Assistance) then 1 (for Colleague). You can also contact Paul
Sherman, VA Center for Engineering & Occupational Safety and Health
(CEOSH) at (314) 543-6700.

January 11, 2002

> Re: **Colleague** Volumetric Infusion Pump
>
> Product Codes: 2M8151, 2N48151R, 2M8l53, 2M8153R
>
> Dear Customer,
>
> Baxter has recently completed an investigation into reports of an
> infrequently occurring malfunction of the on/off circuit in the
> monochrome **Colleague** Volumetric Infusion Pump. We are sending you
> this information so that you will understand the cause, the possible
> consequences, how to prevent it, and what Baxter will be doing to
> correct it.
>
> A malfunction of the on/off off circuitry can occur if fluid enters
> the main body of the pump and, after long-term exposure, causes a
> short circuit A short circuit may then cause an unexpected "power on"
> or "power off" without a key press. Most commonly when the circuit
> shorts, a rapid power on/off cycling occurs. These events may occur
> with or without an alert or alarm and if they should occur during
> patient use, there is a potential that delivery of therapy may be
> interrupted.
>
> Fluid may enter the main pump body if the recommended cleaning
> instructions are not followed or if a significant IV solution spill
> into the pump occurs. Fluids entering the pump may settle on the
> ribbon cable behind the keypad. Over prolonged exposure, the ribbon
> cable may degrade and experience an intermittent short circuit causing
> the behavior described above.
>
> During the next service activity on your pump, an insulator will be
> placed in the area of the ribbon cable to prevent the effect of any
> fluid contact on this circuitry. In the interim, any of the following
> actions will prevent this malfunction from occurring:
>
> • Do not spray cleaning fluid onto the body of the pump or submerge
> the pump for cleaning. Please remember that the **Colleague**
> Volumetric Infusion Pump is not watertight. **Under normal use and
> following the recommended cleaning instructions (attached), cleaning
> fluid will not enter the pump and the behavior described above will
> not occur.**
>
> • As recommended in the **Colleague** User Manual, use the panel
> lockout feature as a standard procedure during infusions. Pressing the
> black Panel Lockout button on the back of the pump will enable this
> feature. When the Panel Lockout is enabled, all inputs from the on/off
> key are ignored and the behavior described above should not occur or
> should it occur, a failure alarm will sound. Alternatively, the
> Autolock feature can he enabled in the configuration for each
> personality. This results in the automatic setting of the Panel
> Lockout 2 minutes after the start of an infusion.
>
> • Install a protective insulator at the location of the ribbon cable.
> This insulator and the installation instructions will be provided to
> you at no charge by calling 1-800-THE-PUMP (1800-843-7867)*.* Press 2
> for Technical Assistance then press 1 for **Colleague** and a
> **Colleague** Technical Expert will assist you with your order.
>
> • If any of your pumps become exposed to excessive fluid from spills
> or inadvertent immersion, please remove the pump from use and contact
> Baxter to schedule service.
>
> • Remove any **Colleague** pumps in your inventory that are reported
> to show this on off/off or similar behavior and contact Baxter to
> schedule service.
>
> Please do not hesitate to contact your Baxter Infusion System sales
> representative or 1-800-THE-PUMP with any questions. The Food and Drug
> Administration has been notified of this action.
>
> ***In order to avoid receiving a repeat mailing of this letter, please
> complete the attached** **reply record and return it by FAX to one of
> the numbers on the reply record.***
>
> We sincerely apologize for the inconvenience that this situation
> causes to you and your staff. Thank you for your assistance.
>
> Sincerely,

Cathy Buhner

> Manager, Quality Management
>
> Baxter Healthcare Corporation

**Colleague Volumetric Infusion Pump Cleaning Instructions**

Please post in all pump cleaning areas

> Prior to cleaning the pump, read this procedure carefully. Follow this
> procedure to ensure that the pump is not damaged during cleaning and
> remains under Baxter warranty. Contact your authorized Baxter Service
> Center for further information.

CAUTIONS

**• Do not use hard instruments for cleaning.**

**• Do not spray liquids or foam directly on** **the pump.**

**• Do not submerge the pump into liquids of any kind.**

**• Do not clean, disinfect, or sterilize any part of the pump by
autoclaving or with the use of 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: acetaldehyde, acetone, ammonia, benzene,
hydroxytoluene, methylene chloride, or ozone. Do not use cleaners
containing n-alkyl dimethyl ethyl benzyl ammonium chloride.**

Cleaning the Exterior

> Clean the pump after each use with soapy water, a solution of 10%
> bleach and water, isopropyl alcohol (up to 95%), or a commercial
> cleaning solution that does not contain any of the ingredients listed
> above. Follow the manufacturer's dilution instructions for
> concentrated cleaners. Clean the exterior using a soft cloth sparingly
> dampened, not soaked, with cleaning solution. To clean pumps that have
> been in an isolation area, select a cleaner that cleans and
> disinfects.

**Colleague** Infusion Pump

January 11, 2002 Letter

Reply Record

Please complete and return this record to either FAX number listed
below.

\(847\) 270-2531 OR (847) 270-4022

Reply Record Completed

By:

(Please print name)
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Title:

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Telephone Number:
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Signature/Date:

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Facility Name and Address:
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