Medical Device Safety and Recalls: CareFusion Alaris Syringe Pump, Alarm Error May Cause Interruption of Therapy

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: CareFusion Alaris Syringe Pump, Alarm Error May Cause Interruption of Therapy

A recall has been issued for the CareFusion Alaris Syringe Pump. An error in the syringe pump triggers a visual and audible alarm and causes the pump to stop supplying the infusion to the patient. Even when the user clears the error code 351.6740, the syringe pump does not respond to key presses until the product is detached and reattached to the PC unit used to program, monitor and provide power to the syringe pump. Failure of syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death.

CareFusion has received 108 reports of the issue occurring. There have been no reports of permanent injury or death.

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