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U.S. Department of Health and Human Services

Safety

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Baxter Healthcare Corp. COLLEAGUE and COLLEAGUE CX Volumetric Infusion Pumps 04/28/2006

Audience: All healthcare providers, risk managers, and biomedical engineers
[Posted 04/28/2006] The FDA is recommending that all healthcare providers take important safety steps when using the COLLEAGUE Volumetric Infusion Pump manufactured by Baxter Healthcare Corporation. The COLLEAGUE pump has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm. Over the past year, Baxter has issued four urgent safety notices and recalls for COLLEAGUE infusion pumps.

In addition to the recommendations made by Baxter Healthcare Corporation when using the COLLEAGUE Volumetric Infusion Pump, FDA is strongly recommending the following measures:

  • Do not use the COLLEAGUE pumps in situations where delaying or interrupting therapy in order to reprogram or replace a malfunctioning pump may be life threatening, if possible.
  • Have a contingency plan to mitigate any disruption of infusion therapy (e.g., have a back-up pump available).
  • Monitor patients and check the pumps frequently.
  • Report any problems as soon as possible to Baxter and FDA.
  • Consider evaluating other options for infusion therapy if your facility relies primarily or entirely on COLLEAGUE Pumps.

Other short-term options that may be appropriate for certain IV therapies include gravity drip and flow control devices (e.g., buretrol, volutrol, micro tubing, and flow control tubing devices). FDA is mindful of concerns about the availability of replacement units and is working with Baxter to resolve problems with the COLLEAGUE pump as quickly as possible.

[April 28, 2005 - Preliminary Public Health Notification - FDA]