CRIT-LINE CLIP (CLIC) - USB

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. DURING AN EXTERNAL VISUAL INSPECTION OF THE DEVICE A DRIED SUBSTANCE WAS FOUND ON THE TRANSMITTER COVER. A VERIFY ACCURACY TEST WAS PERFORMED AND FAILED. THE CLIC DEVICE WAS THEN ATTACHED TO A MONITOR WHICH FAILED TO RECOGNIZE IT AND THE CLIC DEVICES RED LIGHT DID NOT ILLUMINATE. A USB CABLE CONTINUITY TEST WAS PERFORMED AND PASSED. AN INTERNAL INSPECTION REVEALED CORROSION AND THERMAL DAMAGE TO THE TRANSMITTER BOARD AND TO THE INSIDE OF THE TRANSMITTER COVER. AN INTERNAL VISUAL INSPECTION OF THE RETURNED CYCLER ENCOUNTERED NO OTHER DISCREPANCIES. A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND VERIFIED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. UPON COMPLETION OF THE EVALUATION, THE CUSTOMER'S REPORTED ISSUE OF THE CLIC'S FAILURE TO VERIFY WAS CONFIRMED.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THE CRIT-LINE CLIP (CLIC) DEVICE WOULD NOT VERIFY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER TO DATE A RESPONSE HAS NOT BEEN RECEIVED. THE CLIC DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN INTERNAL INSPECTION OF THE CLIC DEVICE REVEALED CORROSION AND THERMAL DAMAGE TO THE TRANSMITTER BOARD AND TO THE INSIDE OF THE TRANSMITTER COVER.