MEDFUSION INFUSION PUMP

Additional Manufacturer Narrative

ONE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS NOT PERFORMED HOWEVER FUNCTIONAL TESTING WAS PERFORMED. THE TESTING COULD NOT DUPLICATE THE CUSTOMER REPORTED PROBLEM AS NO EVIDENCE OF A HARDWARE ISSUE. THE ROOT CAUSE OF THE ISSUE WAS NOT DETERMINED AS NO PROBLEM WAS FOUND. NO FURTHER ACTION. THE SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE WAS HAVING AN AUXILIARY CONTROL UNIT WATCHDOG ERROR. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.