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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P05-45
July 21, 2005

Media Inquiries:
Julie Zawisza, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Announces Class I Recall of Baxter Healthcare's Colleague Volumetric Infusion Pumps

The U.S. Food and Drug Administration (FDA) is announcing that Baxter Healthcare Corporation of Deerfield, Ill., has initiated a worldwide recall of all models of its Colleague Volumetric Infusion Pumps because they can shut down while delivering critical medication and fluids to patients. Baxter has received six reports of serious injury and three reports of death associated with this shut-down problem. The affected are: Models 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.

Based on information from a current FDA inspection and independent analysis of the failure modes by FDA's Office of Science and Engineering Laboratories, as well as a comprehensive review of adverse event reports in FDA's database, FDA has determined that this action is a Class I recall. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the affected product will cause serious injury or death.

"Given the widespread use of these pumps and the multiple failure modes, FDA is quickly informing users of this important safety issue," said Daniel Schultz, M.D., Director of FDA's Center for Devices and Radiological Health. "We will continue to monitor the situation closely and inform the public immediately of any new developments."

The firm notified customers today that it has voluntarily stopped shipping Colleague Volumetric Infusion Pumps until the problems are resolved. Baxter also advised customers on March 15, 2005, to stop using any pumps that exhibit a failure code beginning with 402, 403, 533, 535, or 599, related to these electronic problems. Additionally, Baxter advised customers to take out of service any pumps that exhibit failure codes 810:04 and 810:11 related to air-in-line sensor problems, until they are inspected by authorized service personnel.

In addition to the shut-down problem, the device may exhibit two additional failure modes:

  1. Users may inadvertently press the on/off key instead of the start key when attempting to start an infusion.
  2. Disconnecting or connecting the pump from the hospital monitoring system while the pump is powered "on" can result in a failure code, requiring the infusion to be restarted.

Also, these failures may occur during the infusion of therapy, so it is imperative that health care institutions have a contingency plan to mitigate any disruptions of infusions of life-sustaining drugs or fluids.

Approximately 255,000 Colleague Volumetric Infusion Pumps are currently in use, including 206,000 distributed in the United States. They have been sold to physicians, hospitals, pharmacies, and a variety of other medical facilities.

At this time, users should not return the pumps to Baxter.

Baxter's letters to customers are available on its web site at www.Baxter.com. Consumers who have questions about the recall may contact Baxter Healthcare at 1-800-422-9837. Those who have technical questions may contact Baxter Healthcare at 1-800-THE-PUMP (800-843-7867).

If you are a physician or a patient who has experienced a problem with any of these infusion pumps, please send a report to FDA's MedWatch program and to Baxter. See  http://www.fda.gov/medwatch/ for filing information or call 1-800-FDA-1088 (1-800-332-1088).

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