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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.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.

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