Urgent Device Correction Letter: COLLEAGUE Single Channel and Triple Channel Volumetric Infusion Pumps - For Health Professionals

Starting date:

January 29, 2009

Posting date:

April 3, 2009

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002053

This is duplicated text of a letter from Baxter Corporation Canada.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on COLLEAGUE Single Channel and Triple Channel Volumetric Infusion Pumps

January 29, 2009

Re: COLLEAGUE Single Channel and Triple Channel Volumetric Infusion Pumps Models: Mono, CX and CXE

Product Codes: 2M8151, 2M8151K, DNM8151, 2M8153, 2M8153K, DNM8153, 2M8161, 2M8163, 2M9161, DNM9161, 2M9163, DNM9163. (Includes all internal suffix codes)

Dear Director of Biomedical Engineering,

Baxter Corporation Canada is providing this letter to address the following issues concerning the COLLEAGUE Volumetric Infusion Pump: Failure Codes, Hazards Associated with Improper Cleaning and Damaged Battery Messages.

Failure Codes That Cause the Pump to Alarm and Interrupt Infusion:
The COLLEAGUE infusion pump continuously monitors sensors, electronics and control software. It is designed to alarm, stop infusing and display a failure code if this monitoring detects an unexpected situation.

Baxter has identified the following failure codes that lead to an interruption of therapy. An interruption of therapy may lead to serious injury and/or death.

Because failure codes can occur during the infusion of any therapy, Baxter advises institutions to have a contingency plan that includes verifying that back-up pumps are available in your inventory to address any disruptions of infusion of life sustaining drugs or fluids.

Failure Codes 703:00, 701:00, 701:01, 401:317:850:0000 and 403:317:871:0000
If these failure codes occur the pump is designed to stop the infusion and sound an alarm. These failure codes are generated when the pump detects an internal communications error. Internal communications errors can occur when one of the three (3) separate data processors contained within each COLLEAGUE pump fails to respond as expected to messages given by one of the other data processors. The main data processor continually monitors the hardware assuring the pump is operating correctly and that the other processors within the pump are receiving, processing and responding to commands. If the expected reply message is not received within a set time frame, failure codes 401, 403, 701, or 703 are issued. The user cannot prevent the occurrence of these events.

Baxter does not have corrections for this issue available at this time. However, new steps for addressing an interruption of therapy with any failure code are included in the enclosed instructions.

Failure code(s) FC4:311:1545:XXXX or FC4:311:1985:5353:

The latest revision of UI Master Software (5.09.92, 5.x8.92, 6.x3.92) in COLLEAGUE pumps provides a correction for this failure code. Your facility may currently have a mix of software in your pump population. Please refer to appendix C of this communication for steps to confirm the version of software in a device.

If the 4:311 failure code occurs, the pump is designed to stop the infusion and sound an alarm. These failure codes are identical and one or the other will occur depending on the version of software within a COLLEAGUE pump, under two different scenarios. The first scenario can happen when a downstream occlusion occurs, temporarily stopping the infusion just as the volume to be infused (VTBI) on a piggyback infusion has reached 0.0mL. If the downstream occlusion resolves and the system automatically re-starts the infusion, this failure code will occur. The failure code is issued because the data processor is receiving conflicting messages and cannot determine how to process these messages. The piggyback VTBI has been completed (VTBI=0.0ml) but the clearance of the downstream occlusion tells the pump to restart the infusion even though there is no volume left to infuse thus resulting in conflicting messages. This scenario requires the events leading to this failure code to occur within a specific time frame. If the downstream occlusion occurs and clears while there is VTBI above 0.0mL or the down stream occlusion occurs and clears after a VTBI has been completed, no 4:311 failure code will be issued. The user cannot prevent this particular scenario from occurring. The number of complaints that Baxter has received on this issue are minimal.

A second scenario where these failure codes can occur is when the caregiver presses 'START' and the VTBI of a piggyback infusion has reached 0.0mL. To prevent these failures, caregivers should not press the 'START' key when the VTBI approaches 0.0mL. The caregiver should not program a change to a piggyback infusion that would be started when the VTBI is approaching 0.0mL. While pressing the "START" key at this point in time is ordinarily not an issue, Baxter is aware of specific instances where the caregiver had previously set up a primary infusion and a piggyback infusion.

For Example: When monitoring a patient, the caregiver changed the piggyback infusion and pressed the "START" key just when the VTBI reached 0.0mL. The pump issued the 4:311 failure code. The failure code is issued because the data processor is receiving conflicting messages and cannot determine how to process these messages. The VTBI has been completed (VTBI=0.0ml) but the pump receives a start message from the keypad. The start message tells the pump to implement the change however there is no volume left to infuse with the change thus the conflicting messages. This scenario requires the events leading to this failure code to occur within a specific time frame. Please note if the "START" key is pressed while there is VTBI above 0.0mL, the 4:311 failure code will not be issued.

Steps for addressing an interruption of therapy with any failure code with Single or Triple channel COLLEAGUE Pumps

When a failure code affects ALL channels:

1. The caregiver should immediately request a replacement pump from inventory. The risk to the patient should be assessed and other appropriate means of continuing the infusion should be implemented.
2. If there is a delay in obtaining a replacement pump, attempt to re-start the pump.
   • Close the regulating clamp(s) on the I.V. administration set(s) (to prevent free-flow).
   • Turn the pump 'off'.
   • Any open channel must be closed using the Manual Tube Release (MTR).
   • Then power the pump 'on'.
3. The power for the pump should only be cycled 'off' and 'on' ONE time. If a failure code occurs after the power cycle, stop using the pump. Put the replacement pump into service.
4. Any sets removed in Step 2 should now be re-loaded into the SAME channel.
5. If any channel opens after you cycle the power "off" and "on":
   • Re-load the set into the SAME channel.
6. The previous programming should be retained:
   • Verify the programming for each channel.
   • Open the regulating clamp(s).
   • Re-start the infusion on each channel.
7. Caregivers should closely monitor the pump and the patient until the replacement pump arrives and is put into service.
8. The "failed" pump must be swapped with the replacement pump as soon as clinically safe, then taken out-of-service. Biomedical engineers should proceed with trouble-shooting according to instructions provided in the Service Manual and report the failure to Baxter.

If the failure code interrupts ONE or TWO channels of a triple channel pump:

• The caregiver should immediately request a replacement pump from inventory. The risk to the patient should be assessed and if the infusion must be continued immediately, clinically acceptable means of continuing the infusion without the pump should be implemented.
• Do not attempt to cycle the power 'off' then 'on'.
• You may continue the infusions on the operating channel(s) and replace the pump as soon as clinically appropriate.

The steps for addressing an interruption of therapy represent a change to Operator's Manual Instructions. Please store the attached Addendum "A" with your Operator's Manual.

Important Product Information

Information About Hazards Associated with Improper Cleaning
Baxter has received complaints of electrical short circuits caused by improper cleaning that have resulted in overheating, including smoke emitting from the pump. While no patient impact has been reported, there has been one report of medical staff exposed to smoke requiring medical evaluation. Failure to follow the cleaning instructions in the user manual may cause damage to the pump, which may cause the pump to malfunction and/or generate a smoke/fire hazard.

To avoid ingress of cleaning fluid, it is important to follow the instructions for proper cleaning provided here in Addendum "B".

Information Related to Damaged Battery Message
A higher than expected occurrence of Damaged Battery messages has been reported for COLLEAGUE pumps installed with software versions 5.x8.90, 5.09.90, 6.x3.90 or later.

When a Damaged Battery message occurs, the pump will display the message: "Damaged Battery! Service now". If you experience a Damaged Battery message, you must:

1. Take the affected pump out-of-service, and
2. Install new batteries with their new battery harness prior to clearing the damaged battery message.

Failure to install new batteries and a new battery harness after a Damaged Battery message may result in unpredictable battery performance and potential interruption of therapy.

Baxter has created multifaceted training programs, titled "Keep it Green" (for CX and CXE models) and "Keep it Fully Charged" (for Mono models) which address the importance of maintaining a high charge-level by keeping the device plugged in. If you have COLLEAGUE software version 5.x8.90, 5.09.90, 6.x3.90 or later, please indicate on the enclosed reply form if your facility has received training or would like to receive further information on the "Keep it Green" or "Keep it Fully Charged" programs. Addendum "C" provides the steps to confirm the version of software of a device.

Please complete the attached reply form confirming your receipt of this letter and fax it to Baxter at the number provided on the form. Returning the form promptly will prevent you from receiving a repeat notice. Additionally, if you provide COLLEAGUE pumps to other facilities, please forward this information to them immediately. It is imperative that all end users of the affected COLLEAGUE pumps be notified.

Health Canada has been notified of this action.

Baxter Corporation Canada is committed to continuously improving the safety and effectiveness of our products. We apologize for any inconvenience this may cause you and your staff. If you have any questions concerning this communication, please do not hesitate to contact your local sales representative.

Baxter Corporation Canada
4 Robert Speck Parkway
Mississauga, ON
L4Z 3Y4

Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.

For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Sincerely

original signed by

Pam Bobbette
Vice President, Quality
Baxter Corporation Canada

Addendum A: Optional ONE TIME power cycling

Steps for addressing an interruption of therapy with any failure code that affects all channels of a COLLEAGUE infusion pump (single or triple channel).

When a failure code affects ALL channels:

1. The caregiver should immediately request a replacement pump from inventory. The risk to the patient should be assessed, and if the infusion must be continued immediately, clinically acceptable means of continuing the infusion without the pump should be implemented.
2. If there is a delay in obtaining a replacement pump, attempt to re-start the pump.
   • Close the regulating clamp(s) on the I.V. administration set(s) (to prevent free-flow).
   • Turn the pump 'off'.
   • Any open channel must be closed using the Manual Tube Release (MTR).
   • Then power the pump 'on'.
3. The power for the pump should only be cycled 'off' and 'on' ONE time. If a failure code occurs after the power cycle, stop using the pump. Put the replacement pump into service.
4. Any sets removed in Step 2 should now be re-loaded into the SAME channel.
5. If any channel opens after you cycle the power "off" and "on":
   • Re-load the set into the SAME channel.
6. The previous programming should be retained:
   • Verify the programming for each channel.
   • Open the regulating clamp(s).
   • Re-start the infusion on each channel.
7. Caregivers should closely monitor the pump and the patient until the replacement pump arrives and is put into service.
8. The "failed" pump must be swapped with the replacement pump as soon as clinically safe, then taken out-of-service. Biomedical engineers should proceed with trouble-shooting according to instructions provided in the Service Manual and report the failure to Baxter.

If the failure code interrupts ONE or TWO channels of a triple channel pump:

• The caregiver should immediately request a replacement pump from inventory. The risk to the patient should be assessed and if the infusion must be continued immediately, clinically acceptable means of continuing the infusion without the pump should be implemented.
• Do not attempt to cycle the power 'off' then 'on'.
• You may continue the infusions on the operating channel(s) and replace the pump as soon as clinically appropriate.

Addendum B - Instructions for cleaning

Clean the exterior of the pump after each use using a soft cloth, sparingly dampened with soapy water, a solution of 10% bleach and water, or isopropyl alcohol (up to 95%), or use a commercial cleaning solution that does not contain any of the chemicals listed in the Caution statement below. Always clean/disinfect the pump after each use.

The pump's design helps safeguard fluid spillage into the pump module.

!WARNING!

• Do not allow fluid to enter the tubing channel or load wet tubing into the pump. Contact your Baxter Service Center for assistance immediately if fluid enters the tubing channel. The tubing channel should be cleaned as soon as possible by Baxter-trained, qualified personnel to minimize potential difficulties caused by fluid pooling and drying on the mechanism. Fluid in the tubing channel can also cause false Air In Line alarms.

!CAUTIONS!

• 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, hydroxytoluene, methylene, chloride, and ozone. Do not use cleaners containing n-alkyl dimethyl ethylbenzyl ammonium chloride.
• Do not spray cleaners directly into the tubing channel or the area where the power cord enters the pump.
• Do not use hard instruments for cleaning.
• Do not submerge the pump into liquids of any kind.

Addendum C:

Steps to confirm the version of software in a device

1. Power the device on and perform the 'Speaker' test, if prompted,
2. Select the 'Options' soft key from the main display,
3. Press the 'Up' arrow key to highlight the configuration service,
4. Press the 'Select' key to view the software version displayed.

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This HTML document is not a form. Its purpose is to display the information as found on the form for viewing purposes only. If you wish to use the form, you must use the alternate format below.

[NJS_FILE:3311bdad-28b4-40a2-8077-a66dbc3cbc0f:57d3b27e-fb88-4f22-8a0c-d9cb48d5abb4]

Re: COLLEAGUE Single Channel and Triple Channel Volumetric Infusion Pumps
Models: Mono, CX and CXE

Product Codes: 2M8151, 2M8151K, DNM8151, 2M8153, 2M8153K, DNM8153, 2M8161, 2M8163, 2M9161, DNM9161, 2M9163, DNM9163. (Includes all internal suffix codes)

Customer Reply Form (Urgent Device Correction letter dated January 29 2009)

Please complete and return one copy of this form per facility to the FAX number listed below as confirmation that you have received this notification. A fax cover sheet is not required.
Fax 905-281-6625

Facility Name and Address: (Please Print)

Reply Confirmation Completed By: (Please Print Name)

Title: (Please Print)

Email Address:

Telephone Number:

Please list Software versions currently at Facility

We have received and understand the contents of the letter; performed the actions as outlined in this letter as needed; and have disseminated this information to our staff and to other facilities, as applicable.

If you have COLLEAGUE software version 5.x8.90, 5.09.90, 6.x3.90 or later, please check one of the following:

My institution has received "Keep it Green" or "Keep it Fully Charged" training.

I would like to receive further information on the "Keep it Green" or "Keep it Fully Charged" programs.

Signature/Date :

2008FCA18/2008-056-MD
COLLEAGUE and Baxter are registered trademarks of Baxter International, Inc.