The US FDA is announcing that Baxter Healthcare Corporation 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.
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, director of FDA's Centre for Devices and Radiological Health.
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. The affected are: Models 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.
Approximately 255,000 Colleague Volumetric Infusion Pumps are currently in use, including 206,000 distributed in the United States.