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Baxter Reports More Problems with COLLEAGUE Infusion Pumps, Issues Class I Recall

Mar 11, 2009 | Parker Waichman Alonso LLP

Baxter International has issued a Class I recall for some of its U.S. COLLEAGUE Volumetric Infusion Pumps.  Baxter had sent an Urgent Device Correction letter to customers regarding the infusion pumps in January, but announced today that the Food & Drug Administration (FDA) deemed the action a Class I recall because of the risk of serious injury or patient death if the affected pumps malfunction.

The recalled Baxter  COLLEAGUE Infusion Pumps are designed to monitor a variety of sensors, electronics and medical-control software during patient therapy, and to automatically shut down and sound an alarm in the event of an unexpected or potentially dangerous situation.  The January 23, 2009 Urgent Device Correction Letter notified customers about failure codes in COLLEAGUE pumps that could cause them to alarm and stop infusing while delivering critical medication and fluids to patients.

The letter also included information warning of the possibility of the device overheating resulting in smoke and fire if improperly cleaned and/or if there is compromised battery harness insulation. Additionally, Baxter notified customers about a high occurrence of damaged battery messages related to the use of the pump as a battery-operated device.

In today's recall notice, Baxter said there have been serious injuries and/or deaths associated with failures identified in the Urgent Device Correction letter.

This recall involves all COLLEAGUE Volumetric Infusion Pump Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161 and 2M9163.

According to The Chicago Tribune, Baxter hasn't sold the Colleague infusion pump in the U.S. since 2005, because of a number of defects.  These problems include battery failures, problems with false alarms and alarm failures, and  inadequate infusion. But pumps remain in service, and are used in hospitals and clinics for medical-infusion treatments, the Tribune said.

Customers with questions regarding this recall may contact Baxter at 1-800-THE-PUMP (1-800-843-7867), between 7 a.m. and 5 p.m. CDT. Any adverse events relating to this product should be reported to Baxter.