Carefusion Alaris Infusion Pump Recall Issued Over Defective Motors

Defective motors have led to the recall of Carefusion Alaris drug infusion pumps, which federal regulators indicate could cause serious injury or death.  

The FDA announced this week that it was giving a recent Carefusion Alaris infusion pump recall a Class I medical device recall designation, which is reserved for the most serious types of medical device problems and means that the agency believes there is a reasonable probability that the infusion pumps will cause severe injury or death.

The recall was initiated by Carefusion on July 20, after customer reports indicated that the model 8100 Alaris infusion pump motors were malfunctioning. The reports generally indicated that the motor would stall out at high infusion speeds.

A failed motor on an infusion pump may cause the device to not administer important medications into a patient’s body, which could result in a life-threatening situation. The motor stalling causes the device to bring up a visual error code 242.4030 and an audible alarm.

The recall affects the Alaris Pump Module, model 8100, which is used with the Alaris electronic infusion pump system.  The recall affects pump modules manufactured between August 1, 2010, and July 31, 2011. Carefusion has posted a list of affected serial numbers (pdf).

In its original letters to customers, Carefusion cautioned doctors to consider using other devices for high-risk patients.

This is the second major Alaris pump recall. In October 2010 about 17,000 were pulled from the market due to software problems that caused the Alaris PC unit to freeze. The problem was linked to a communication error through the unit’s wireless network. That recall was also classified as a Class I by the FDA.