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Important Safety Information on the Recall of Certain Baxter Colleague Volumetric Infusion Pumps- Baxter Corporation

Date: 2005-08-10

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NOTICE TO HOSPITALS
Important Safety Information on the Recall of Certain Baxter Colleague Volumetric Infusion Pumps

Attached is a letter that Baxter Corporation sent to users of its Colleague Volumetric Infusion Pump on July 21, 2005. Health Canada is in discussion with Baxter Corporation with respect to this recall. An update will be available on Health Canada’s website as further information is provided.

Baxter Corporation
4 Robert Speck Parkway, Suite 700
Mississauga, Ontario L4Z 3Y4
905.270.1125

July 21, 2005

Dear Director of Biomedical Engineering:

Baxter Corporation is sending this communication to provide you with important information concerning COLLEAGUE Infusion pumps. We have detected a design issue with the COLLEAGUE Infusion pumps, which may have been associated with a patient death. This design issue involves a clocking circuit contained in the pump that can disrupt internal communications in some devices.

We recommend that any pump that displays any of the following failure codes: 402, 403, 532, 533, 534, 535, 599, 702, 703, 704, 720, 804:21, 804:22, 804:24, 804:29, 804:34, 804:52, 804:54, 804:58 and 12:303:xxx:0006 be taken out of service. Failure codes 402, 403, 533, 535 and 599 were previously mentioned in our Urgent Device Correction letter dated March 29, 2005. You should also review the event history of your pumps and any pumps with a previous history of the aforementioned failure codes should be taken out of service. If you have any questions on how to access the event history, please refer to the enclosed page from the Service Manual or call Baxter Medication Delivery Services at 1-800-THE-PUMP.

COLLEAGUE pumps are designed to alarm, stop infusing, and display a failure code if it detects an abnormal situation. Because this situation can occur during an infusion, it is imperative that institutions have a contingency plan to mitigate any disruptions during infusion therapy (e.g. have a back-up pump available). Additionally, you should consider not using these pumps in situations where a replacement pump is not available or where a delay in therapy may be life threatening.

All pumps currently being processed through Baxter's service operations will be checked by reviewing the event history, before return to the customer, for any of the failure codes listed above. If a pump is found to have any of these failure codes, it will not be returned to you until a corrective action has been implemented. The company will voluntarily hold shipments of new COLLEAGUE pumps until the issue is resolved.

Baxter is currently developing an aggressive action plan to address this issue and we will immediately notify you once it is finalized.

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

We apologize for any inconvenience this will cause you and your staff. Please contact your Baxter Representative if you have questions regarding this communication.

Health Canada has been notified of this action.

Sincerely,

original signed by

Dirk E. Stevens
Vice President, Quality
Medication Delivery Division
Baxter Healthcare Corporation

COLLEAGUE and Baxter are registered trademarks of Baxter International, Inc. 2005FCA21