The FDA sent out the highest-risk recall notice for the an infusion pump made by CareFusion (NYSE:CFN), the most recent warning to customers involving the company’s Alaris product line.
Following customer reports of an "error" message on the pump’s PC computer system, the company issued a warning notice, which the FDA followed up with a Class I recall, reserved for device malfunctions that have the potential to cause serious harm or death.
A voltage problem can cause a loss of communication between the device’s main processor and its keyboard processor, according to the FDA’s recall notice. The Alaris infusion pump is designed to deliver a steady and controlled amount of medication intravenously.
The PC component, model 8015 with software version 9.12, may show a communication malfunction, which presents as a "system error" or "channel disconnected" message. Nurses or hospital staff might accidentally stop a patient’s medication infusion by pushing the "System On" button, which could result in serious injury or death, according to the recall notice.
CareFusion has set up a hot-line for customers who might experience this problem. The malfunctioning units were sold from Sept. 2012 to May 2013.
San Diego-based medical device company landed Class I recall earlier this year for the same Alaris PC model and software version. Again, the problem was a communication error, and in this instance the error cropped up when the device was attached to EtCO2 or SpO2 modules.
UPDATED August 12, 2013 with more information on the reason for the recall.