MEDFUSION

Additional Manufacturer Narrative

ONE PUMP WAS RETURNED FOR ANALYSIS IN USED CONDITION. THE DEVICE HAD NOT BEEN PREVIOUSLY SERVICED AS THIS WAS AN OUT OF BOX ISSUE. VISUAL INSPECTION FOUND THE BATTERY PACK IS IN GOOD CONDITION. THERE WAS NO DAMAGE OR CONTAMINATION. THE ITEM IS A PURCHASED FINISHED GOOD, A DEVICE HISTORY REVIEW IS AT THE SUPPLIER. FUNCTIONAL TESTING WAS ABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM DURING THE BATTERY CHARGING CYCLE. NO CHARGING CURRENT OR CAPACITY WAS NOTICED ON THE DEVICE AFTER FEW HOURS OF CHARGING. THE INVESTIGATION DETERMINED THE CAUSE OF THE ISSUE WAS A DEAD BATTERY, MOST LIKELY DUE TO DEAD CELLS IN THE BATTERY PACK. THE DEFECTIVE BATTERY PACK IS NOT EVALUATED OR TESTED IN ANY WAY DURING OUR INTERNAL MANUFACTURING PROCESS AND THE MANUFACTURING RECORDS ARE RETAINED BY THE SUPPLIER AT THEIR MANUFACTURING SITE AND ARE NOT READILY AVAILABLE FOR REVIEW.

Description of Event or Problem

IT WAS REPORTED THAT THE BATTERY WAS DEFECTIVE AND DID NOT WORK. THERE WAS UNKNOWN PATIENT INVOLVEMENT. CATALOG NUMBER REPORTED WAS 22-4050-51. LOT NUMBER REPORTED WAS MN190522. THESE REPORTED ITEM NUMBERS CANNOT BE VERIFIED.

Additional Manufacturer Narrative

B3: UNKNOWN. E1 - INITIAL REPORTER FULL PHONE NUMBER PROVIDED: (B)(6). H3: DEVICE NOT RECEIVED BY MANUFACTURER. H4: MANUFACTURE DATE IS NOT AVAILABLE BASED ON THE REPORTED CATALOG AND LOT NUMBERS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.