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U.S. Department of Health and Human Services

Safety

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Baxter Healthcare Colleague Volumetric Infusion Pumps

Audience: Hospital Nursing Administrators, Risk Managers and other healthcare professionals

[Posted 07/21/2005] Baxter Healthcare Corporation and FDA notified healthcare professionals of a Class I 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, 2M8163R. 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. 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.

[September 19, 2005 - Recall Notice - FDA]
[July 22, 2005 - Recall Notice - FDA]
[July 21, 2005 - News Release - FDA]