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Baxter Healthcare Corp. Intravenous Pump Recall

On July 21, 2005, the US Food and Drug Administration (FDA) announced that Baxter Healthcare Corporation was initiating an immediate worldwide recall of all models of its Colleague Volumetric Infusion Pumps due to reports that the pumps can shut down unexpectedly while delivering life-sustaining medications and fluids to patients.

Baxter Healthcare Corporation, a division of Baxter International, is coordinating a recall that involves in excess of 206,000 units in the United States after reports of three deaths and six "serious injuries" when the pumps unexpectedly shutdown in clinical environments.

The recalled pumps include Models: 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.

Interestingly, the problem seems to be a possible design defect leading to the unexpected shutdown of the IV Pump. While the FDA news release alludes to a variety of issues, it's also noted prominently that one of the most fundamental problems with the pump's design is the location of the On/Off switch and it's proximity to the "start" key. In some cases nurses have shut the machines down when they were under the mistaken belief that they had just initiated IV therapy with the Baxter system.

Baxter's popular intravenous pumps are used by hospitals, physicians, and other medical professional nationwide. Since so many hospitals and patients are dependent on this IV infusion pump model, the FDA warns medical professionals to utilize alternative IV delivery systems if they are available, or to continue using the Baxter systems following the strict criteria of proper device use. The FDA asks clinicians and patients to contact Baxter or the FDA MedWatch Program with concerns or reports.

Based out of Deerfield, Illinois, Baxter has stopped shipping the pumps and they are actively working on design changes to be implemented as quickly as possible with FDA approval. Despite the recall, Baxter has realized a significant profit this year, up $80 million in second quarter earnings.

Baxter Healthcare Class I Recall News

Baxter issues major recall of their intravenous pumps and plans on repairing each pump which may cost approximately $65 million. (Jul-22-05) [CHICAGO TRIBUNE]

The FDA states that they have received hundreds of complaints about the system and they go on further to say that in their experience, this is "extraordinary." The FDA announced this as a Class I recall, the most serious level of recall, in which there is a reasonable possibility of death or injury associated with the use of the medical device. (Jul-21-05) [FDA]

Register your Baxter Defective IV Pump Complaint

If you or a loved one were hospitalized or in a similar clinical environment and experienced any significant problems with or a failure of an Intravenous Infusion Pump with a resulting injury, illness or death, please click the link below to submit your complaint and we will have a lawyer review your case.

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