Baxter Pump Attorney Philadelphia, Pennsylvania, New Jersey and Delaware 800-597-9585

The U.S. Food and Drug Administration on July 21, 2005 announced the recall of 255,000 pumps manufactured by Baxter Healthcare Corp. because the intravenous pumps can inadvertently shut down, depriving patients of needed medicine.

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In its announcement, the FDA specified the reason for the recall: “The pumps can shut down while supplying critical medication and fluids to patients. Critically ill patients needing continuous delivery of life-sustaining medications at the time of the pumps’ failure could be seriously harmed.”

The FDA said Baxter had received reports of three deaths and six reports of serious injury that occurred when pumps unexpectedly shut down. The recall was a Class I recall, which the FDA said is issued for those that are “the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.”

If you or someone you know was seriously injured or died as a result of using a Baxter medicine pump, you may want to contact an attorney. Kline & Specter, P.C., recognized as a national leader in product liability and pharmaceutical litigation, has some 30 attorneys (several of them also highly skilled doctors) who have the expertise to handle Baxter pump lawsuits.

The recall included all models of Baxter COLLEAGUE Volumetric Infusion Pumps which are used to give controlled amounts of medications and other fluids to patients through a direct line to the bloodstream. Baxter sold 255,000 of the pumps, 206,000 in the United States, to hospitals, physicians, pharmacies and a variety of other medical facilities. The recall was effective worldwide.

An FDA spokesman said the federal agency had received “hundreds” of complaints about the pumps. The New York Times reported that the pumps shut down for a variety of software, wiring and design reasons, while the FDA said one basic problem was that the On/Off switches are so close to the Start key that some nurses mistakenly turned off the pumps when they actually had intended to begin administering medication.

The FDA recommended that consumers who have questions about the recall call Illinois-based Baxter Healthcare at 1-800-422-9837. People who have technical questions were to contact Baxter Healthcare at 1-800-THE-PUMP.

Click here to contact an attorney now about a serious injury or death that may be related to the use of a Baxter Healthcare pump.

FDA Statement 07/21/05

FDA Announces Class I Recall of Baxter Healthcare's Colleague Volumetric Infusion Pumps

The U.S. Food and Drug Administration (FDA) is announcing that Baxter Healthcare Corporation of Deerfield, Ill., has initiated a worldwide 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 are: Models 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.

Based on information from a current FDA inspection and independent analysis of the failure modes by FDA's Office of Science and Engineering Laboratories, as well as a comprehensive review of adverse event reports in FDA's database, FDA has determined that this action is a Class I recall. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the affected product will cause serious injury or death.

"Given the widespread use of these pumps and the multiple failure modes, FDA is quickly informing users of this important safety issue," said Daniel Schultz, M.D., Director of FDA's Center for Devices and Radiological Health. "We will continue to monitor the situation closely and inform the public immediately of any new developments."

The firm notified customers today that it has voluntarily stopped shipping Colleague Volumetric Infusion Pumps until the problems are resolved. Baxter also advised customers on March 15, 2005, to stop using any pumps that exhibit a failure code beginning with 402, 403, 533, 535, or 599, related to these electronic problems. Additionally, Baxter advised customers to take out of service any pumps that exhibit failure codes 810:04 and 810:11 related to air-in-line sensor problems, until they are inspected by authorized service personnel.

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.

Also, 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. They have been sold to physicians, hospitals, pharmacies, and a variety of other medical facilities.

At this time, users should not return the pumps to Baxter.

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