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FDA Preliminary Public Health Notification*: Important Safety Recommendations for Baxter’s COLLEAGUE Infusion Pumps

This is an archived document. It is no longer current information and has been superseded. The latest information can be found at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01571.html

Date: April 28, 2006

Dear Health Care Provider or Biomedical Engineer:

The FDA is recommending that you take important safety steps, in addition to those recommended by the manufacturer, 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. These notices, which are listed below, identify the specific problems and steps that you should take to address them.

We strongly recommend that, in addition to the steps identified by Baxter, you follow these measures:

• If possible, 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, such as with critically ill patients being maintained on inotropic infusions and patients in mobile transfer units .
• Have a contingency plan to mitigate any disruption of infusion therapy (e.g., have a back-up pump available). Your contingency plans should take into account both the patient’s condition and the reasons for the infusion.
• Monitor patients and check the pumps frequently.
• Report any problems as soon as possible to Baxter and FDA
• If your facility relies primarily or entirely on COLLEAGUE Pumps, you may wish to consider evaluating other options for infusion therapy. You can find a complete list of legally marketed infusion pump devices on the FDA’s web site http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm by using “FRN” in the “Product Code” field.

Other 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). However, these are generally considered backup or last-resort measures and we do not recommend them as long-term solutions or as a permanent replacement for the Baxter infusion pump.

FDA is working with Baxter to resolve problems with the COLLEAGUE pump as quickly as possible, mindful of concerns about the availability of replacement units. However, users should understand that at this point we cannot assure that the company’s proposed corrections adequately address the problems encountered with these Baxter pumps. Baxter’s replacement .units have not been cleared for marketing at this time, and will not be cleared until we are able to provide reasonable assurance that they will function reliably to meet user needs.

Existing Baxter Notices

You may obtain paper copies of the notices that Baxter has issued for the COLLEAGUE pump by contacting Baxter at 1-800-843-7867. For your convenience, we have listed these notices below. You may access a notice by clicking on it . Please note that we cannot assure that the recommendations in these notices will fully address problems with the COLLEAGUE pump.

FDA Contact

Office of Surveillance and Biometrics (HFZ-510)
1350 Piccard Drive, Rockville, Maryland 20850
Fax at 240-276-3356, or by e-mail at phann@cdrh.fda.gov

Additionally, a voice mail message may be left at 240-276-3357 and your call will be returned as soon as possible.

FDA medical device Public Health Notifications are available on the Internet at http://www.fda.gov/cdrh/safety.html. You can also be notified through email on the day the safety notification is released by subscribing to our list server. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDACDRH_10.

*CDRH Preliminary Public Health Notifications are intended to quickly share device-related safety information with healthcare providers when the available information and our understanding of an issue are still evolving. We will revise them as new information merits and so encourage you to check this site for updates.

Updated April 28, 2006

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