Class I Recall of Baxter Healthcare Infusion Pumps

If you or someone you love has suffered injury due to the use of Baxter Healthcare’s Colleague Volumetric Infusion Pumps or any other defective medical product, please contact Pritzker | Ruohonen. You can reach us toll-free at 1-888-377-8900, email us at info@pritzkerlaw.com, or submit your situation for review by our legal counsel with our online free consultation form. Senior partner Fred Pritzker has 29 years of experience and has been selected by other attorneys to be included in The Best Lawyers in America.

December 13, 2005 and February 3, 2006 (Updated Recall Information) --The Baxter Infusion Pump recall below was updated to reflect additional problems with the pump, including the following:

Battery Undercharging: The pump’s battery charge level indicator may overstate the battery power level and shut down when operating on battery power if not charged for a full 12 hours following a “low battery” alarm.
False Air Detection Alarms: If the pump’s tubing is stretched or pulled, the pump’s sensors may misinterpret this tension as air in the line, resulting in a false alarm and shutting down the pump.
Gearbox Wear: Worn parts in the pump’s motor can cause the pump to shut down and interrupt therapy.
Under-infusion: If there is an obstruction during tube-loading, the upper jaw of the pump head can be moved out of alignment, resulting in insufficient fluid delivery.
Non-detection of upstream occlusion: Improperly spiked bags, use of a source container which has had all air removed, improper venting of the container, and an unopened air vent above the burette chamber may result in the pump not detecting an upstream occlusion.

Any of these failures may delay or interrupt therapy, which could result in a life-threatening situation for patients, depending on the type of therapy being administered. The FDA has provided additional information in a February 3, 2006, announcement.

July 21, 2005--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.

Baxter's letters to customers are available on its web site at www.Baxter.com. (*Note: Do not contact the company before consulting a product liability lawyer.) Consumers who have questions about the recall may contact Baxter Healthcare at 1-800-422-9837. Those who have technical questions may contact Baxter Healthcare at 1-800-THE-PUMP (800-843-7867).

If you are a physician or a patient who has experienced a problem with any of these infusion pumps, please send a report to FDA's MedWatch program and to Baxter. See http://www.fda.gov/medwatch/ for filing information or call 1-800-FDA-1088 (1-800-332-1088).

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01209.html

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