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October 13, 2005 (Reuters)
Baxter says FDA seizes nearly 7,000 pumps

Baxter International Inc., which earlier this year stopped shipment of a line of intravenous pumps to deal with battery issues, on Thursday said U.S. regulators seized nearly 7,000 of the medical devices.

The U.S. Food and Drug Administration seized about 6,000 Baxter-owned Colleague Volumetric Infusion Pumps and about 850 Syndeo PCA Syringe Pumps, the Deerfield, Illinois-based company said.

Baxter, which saw its shares fall nearly 3 percent, said the seizure only affects its inventory, and not products already on the market. About 250,000 Colleague infusion pumps are currently in use worldwide, including more than 200,000 in the United States, it said. About 5,000 Syndeo pumps, which allow patients to administer pain analgesics, are in use worldwide.

Baxter said it had placed a voluntary hold on shipments of new Colleague and Syndeo pumps earlier this year. The Colleague pumps had battery problems, while the Syndeo pumps had a code issue which caused the pump to stop infusing and send an alarm as well as a problem with the power button.

From MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Colleague Volumetric Infusion Pumps

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 models are as follows:

2M8151
2M8151R
2M8161
2M8161R
2M8153
2M8153R
2M8163
2M8163R

In addition to the shut-down problem, the device may exhibit two additional failure modes:

Users may inadvertently press the on/off key instead of the start key when attempting to start an infusion
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.

Read the complete MedWatch 2005 Safety summary, including a link to the FDA News Release, at:
http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Baxter

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