Baxter Infusion Pumps

Baxter infusion pumps deliver pain medications and other critical drugs intraveneously to ensure rapid reception by the patient. While sometimes used in a hospital setting, Baxter infusion pumps are more commonly employed in home and other non-hospital settings.

In April of 2005, a recall was issued regarding the COLLEAGUE series of Baxter infusion pumps. The COLLEAGUE series has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm. Over the course of the next year, Baxter issued four urgent safety notices and recalls for COLLEAGUE infusion pumps.

In November 2005, Baxter International Inc. commenced the withdrawal of its 6060 Multi-Therapy Infusion Pump after defects in the device caused the death of a patient. The withdrawal was estimated to take roughly 12 months to complete. At that point, the pumps had been linked to one death and two injuries with hundreds more potential injuries due to the large user base of the pumps. Around 34,000 people used the 6060 mode Baxter infusion pump, approximately 30,000 of which reside in the United States.

In June 2006, the manufacturer, Baxter Healthcare Corporation signed a consent decree with FDA detailing the steps that must be taken before the Colleague pump would meet appropriate regulatory requirements and could be sold again. The agreement resolved a court action by FDA that began with the 2005 product seizure.

The FDA and healthcare professionals have been alerted of each associated recall through a series of letters and statements issued by Baxter. A modified Baxter infusion pump was approved by the FDA in February 2007.

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