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On February 25, 2005, Baxter International informed the Food and Drug Administration about a recall of Colleague Volumetric Infusion Pump because of problems with the unit’s power system. The FDA classified this action as a Class I recall, and it affects 206,000 Colleague Volumetric Infusion Pumps in the United States, and 50,000 spread through other countries around the world. The model numbers affected by this recall include: Models 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.
Baxter International experts advised health care professionals to provide backup should the Colleague Volumetric Infusion Pump fail and prevent the device from providing either pain relieving or lifesaving medication. Battery damage allegedly caused by swelling and excessive discharge result in device failure and shut down without providing the pharmaceuticals the patient needs to survive.
Unfortunately battery failure can sometimes happen without advance indication or signal. Four people have died and 10 suffered serious injuries due to malfunctions of this nature. Baxter also alerted the Food and Drug Administration of the possibility that patients may accidentally strike the power button when attempting to start therapy. Worse still, it is possible to accidentally hit the on/off switch during therapy, so medical personnel must have alternate plans in order to prevent possibly life-threatening complications.
If you or someone you love was injured due to the Baxter International Colleague Volumetric Infusion Pump you may be able to take legal action to claim financial restitution for your hardship and loss. Consult a knowledgeable and dedicated defective medical device attorney today.
