Steigerwalt & Associates
05-Sep-2007, 09:23 AM
Welcome to the Volumetric Infusion Pumps thread maintained by Steigerwalt & Associates. If you or someone you love has been injured by this medical device you may have some legal questions regarding your experience or injury. Feel free to post your concerns to our Legal Chat Online and receive prompt feedback from our firm.
Colleague Volumetric Infusion Pumps were recalled by the U.S. Food and Drug Administration (FDA) in December of 2005. As a result of the recall, Baxter Healthcare notified healthcare professionals and consumers via letter of a class 1 and worldwide recall of all models of the device.
The reason for the recall was multiple malfunctions preventing the device from delivering critical medications and fluids to patients. The damaging information was discovered during an FDA inspection. The inspection was launched to review adverse events related to use of the pumps that included six reports of serious injury and three deaths.
Failure has also resulted from inadvertent use of the on/off key rather than the start key to begin an infusion, and disconnection or connection of the pump from the hospital monitoring system while the device is powered on.
Hospitals are advised to develop a contingency plan for administration of life-sustaining drugs or fluids due to the failure rate and recall of the infusion pumps.
Because pump failure may occur during infusion of therapy, the company has ceased shipment of new pumps pending resolution of the malfunctions. Further information regarding the recall may be obtained by contacting Baxter Healthcare at 1-800-422-9837. Answers to technical questions are available at 1-800-THE-PUMP (800-843-7867).
Please feel free to post any legal comments, questions or concerns and you will receive feedback from our legal staff.
Colleague Volumetric Infusion Pumps were recalled by the U.S. Food and Drug Administration (FDA) in December of 2005. As a result of the recall, Baxter Healthcare notified healthcare professionals and consumers via letter of a class 1 and worldwide recall of all models of the device.
The reason for the recall was multiple malfunctions preventing the device from delivering critical medications and fluids to patients. The damaging information was discovered during an FDA inspection. The inspection was launched to review adverse events related to use of the pumps that included six reports of serious injury and three deaths.
Failure has also resulted from inadvertent use of the on/off key rather than the start key to begin an infusion, and disconnection or connection of the pump from the hospital monitoring system while the device is powered on.
Hospitals are advised to develop a contingency plan for administration of life-sustaining drugs or fluids due to the failure rate and recall of the infusion pumps.
Because pump failure may occur during infusion of therapy, the company has ceased shipment of new pumps pending resolution of the malfunctions. Further information regarding the recall may be obtained by contacting Baxter Healthcare at 1-800-422-9837. Answers to technical questions are available at 1-800-THE-PUMP (800-843-7867).
Please feel free to post any legal comments, questions or concerns and you will receive feedback from our legal staff.