News on the FDA recall of the Baxter's Colleague Volumetric Infusion Pumps
In October 2005, The New York Times reported that battery failures in the pumps have also been linked to patient deaths.
In July 2005, the U.S. Food and Drug Administration (FDA) announced a worldwide recall of all models of Colleague Volumetric Infusion Pumps manufactured by the Baxter Healthcare Corporation after receiving reports of serious injuries and death associated with systematic failures in the devices. The FDA found that affected models can shut down involuntarily while transmitting vital medication and fluids to patients.
Due to the possibility of serious injury or death associated with the use of these products, the recall has been labeled a Class 1 recall, the most serious of its kind. Colleague Volumetric Infusion Pumps are widely utilized in the U.S. to treat seriously ill patients with life-sustaining drugs. Over 200,000 devices have been sold to medical facilities in the U.S.
In addition to the potential for spontaneous shut-down, the positioning of the on/off key next to the start button may cause health care professionals to accidentally turn the pumps off when they meant to start an infusion. Additionally, system failures may occur disconnecting or connecting the device to the hospital monitoring system.
Click here to contact an attorney about serious injury or death related to the use of Baxter's Colleague Volumetric Infusion Pumps.