On Friday, the FDA alerted healthcare professionals of a class 1 recall of certain models of an upgraded triple-channel volumetric infusion pump made by Colleague and Colleague CX. A software malfunction may sound an alarm in the device, showing an error code 16:310:867:0002, which will stop infusing.
An electronic infusion pump delivers controlled amounts of medicine or other fluids to patients through a direct line into the bloodstream (intravenously, intra-arterially, or through an epidural).
“The error occurs when all three channels are in use and a healthcare professional initiates a user interface-intensive command such as overriding the Guardian dose limit feature, displaying the dose mode window, performing dose calculations or performing running rate changes,” the company says in a news release.
So far there have been sixteen injuries reported. All the affected users have been contacted and have had their infusion pumps replaced with alternate devices, such as non-upgraded triple-channel and upgraded single-channel pumps.
From May 14 to June 18, 2007 there have been 4512 defective infusion pumps administered to 427 customers, according to an alert from the FDA’s MedWatch.
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