CRIT-LINE CLIP (CLIC) - USB

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN EXTERIOR VISUAL INSPECTION OF THE RETURNED CRIT-LINE CLIP (CLIC) - USB SHOWED NO SIGNS OF PHYSICAL DAMAGE. THE CRIT-LINE IV MONITOR FAILED TO RECOGNIZE THE CLIC DEVICE AND THE CLIC¿S DEVICE LED DID NOT ILLUMINATE. A VERIFY ACCURACT TEST WAS UNABLE TO BE PERFORMED AS THE MONITOR DID NOT RECOGNIZE THE DEVICE. THE CLIC DEVICE PASSED A CONTINUITY TEST ON THE USB CABLE. AN INTERNAL INSPECTION FOUND FERRITE (RZ100) MISSING AND A FUSE (F100) OPEN ON THE POWER SUPPLY BOARD. THERE WERE CHARRED MARKS ON THE POWER SUPPLY BOARD AROUND THE FUSE (F100) AND FERRITE (RZ100). 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 REPORTED ISSUE WAS CONFIRMED AND THE CAUSE WAS DETERMINED TO BE THE MISSING FERRITE AND OPEN FUSE ON THE POWER SUPPLY BOARD.

Description of Event or Problem

A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS CRIT-LINE CLIP (CLIC) - USB WOULD NOT VERIFY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER TO DATE HAS NOT BEEN PROVIDED. THE CLIC WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON PHYSICAL EVALUATION, CHARRED MARKS ON THE POWER SUPPLY BOARD AROUND THE FUSE AND FERRITE WERE IDENTIFIED.