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U.S. Department of Health and Human Services

Safety

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Baxter Healthcare Corp. COLLEAGUE Volumetric Infusion Pumps and Syndeo Patient Controlled Analgesic Syringe Pump

Baxter Healthcare Colleague Volumetric Infusion Pump
Baxter Healthcare Syndeo Patient Controlled Analgesic Syringe Pump

Audience: Hospital nursing supervisory personnel and risk managers

[UPDATE 02/27/2007] FDA has cleared for marketing a modified Colleague Volumetric Infusion Pump which addresses many of the problems that prompted a series of Class I recalls and a product seizure in 2005. Confusing display screens, software defects, swollen batteries and other defects could have resulted in the pumps either shutting down or under- or over-delivering critical medication and fluids to patients and were associated with serious injuries and deaths.

[Posted 07/07/2006] FDA notified healthcare professionals that Baxter Healthcare will stop manufacturing and distributing all models of Colleague Volumetric Infusion Pump and Syndeo Patient Controlled Analgesic Syringe Pump until the company corrects manufacturing deficiencies and is in compliance with FDA's current good manufacturing practice requirements and the Quality System regulation for devices. FDA will allow the firm to continue to provide routine service maintenance, or to replace components, parts, or accessories for the Colleague and Syndeo Infusion Pumps that were already in the hands of customers before October 12, 2005. The Colleague pump has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm. FDA issued a Preliminary Public Health Notification on April 28, 2006 with recommendations for users.

[February 27, 2007 – News Release – FDA]
[June 29, 2006 – News Release – FDA]