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U.S. Department of Health and Human Services

Safety

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Baxter Healthcare Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps

Audience: Hospital administrators, hospital risk managers, healthcare professionals, and consumers

[Posted July 20, 2007] Baxter Healthcare Corp. and FDA notified healthcare professionals and consumers of a Class I Recall of Baxter Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps, Model numbers 2M8153, 2M8163, and 2M9163. These electronic infusion pumps are used to deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, or other direct line into the bloodstream.

The product was recalled because a software irregularity causes the newly upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels infusing fluids at the same time. There are reports of serious injuries that are associated with this issue. In reported cases, the pump stopped infusing which caused it to activate an audible and a visual alarm. Interruption of life-sustaining therapy could lead to serious injury or death. Remove all the affected triple channel pumps from service immediately. COLLEAGUE customers with questions should contact Baxter Medical Delivery Services at 1-800-843-7867.

[July 20, 2007 - Recall Notice - FDA]