CRIT-LINE CLIP (CLIC) - USB

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H3 PLANT INVESTIGATION: ALTHOUGH IT WAS STATED THAT THE COMPLAINT DEVICE WAS AVAILABLE TO BE RETURNED, TO DATE NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION WAS PERFORMED BY A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES). A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

A USER FACILITY BIOMED TECHNICIAN (BIOMED) REQUESTED A PART NUMBER FOR THE FUNCTION BOARD ON THE 2008T MACHINE. THE BIOMED TECHNICIAN REPORTED ISSUES WITH THE P41 CABLE GROUND POST GETTING A BURNT SPOT. IN ADDITION, THE SIDE USB PORT IS EXPOSED WHEN THE CLIC IS NOT CONNECTED. THE FRESENIUS TECHNICAL SUPPORT REPRESENTATIVE PROVIDED THE REQUESTED PART NUMBER, AND ADVISED THE BIOMED TECHNICIAN TO HAVE THE SIDE USB COVER/FLAP CLOSED WHEN THE PORT IS NOT IN USE. THE BIOMED TECHNICIAN WAS INFORMED THAT FLUID MAY BE GETTING IN THE PORT WHEN THE MACHINE IS WIPED DOWN, RESULTING IN AN ISSUE NEAR THE P41 CONNECTION. UPON FOLLOW-UP WITH THE BIOMED, IT WAS REPORTED THAT THE FUNCTION BOARD HAD A BURN SPOT DUE TO A SHORT. IT WAS REPORTED THAT THE CRIT LINE CABLE WIRING CAUSED THE SHORT/BURN SPOT ON THE BOARD. THE BIOMED CONFIRMED THAT THERE WAS NO BURNING SMELL, MELTING, SMOKE, SPARK, OR FLAME, ONLY THAT IT APPEARED TO BE DISCOLORED AND BURNED. THERE WAS NO OTHER PHYSICAL DAMAGE ON THE BOARD ITSELF. THE ISSUE WAS NOTED DURING NORMAL REPAIR. THE MACHINE HAD NO PAST PROBLEMS FAILING THE ELECTRICAL LEAKAGE TEST AND THERE WERE NO OTHER DAMAGED COMPONENTS NOTED. THE MACHINE WAS NOT PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE CRIT LINE PLUG/CABLES AND FUNCTION BOARD WERE REPLACED WHICH RESOLVED THE ISSUE, BUT IT WAS REPORTED THE MACHINE IS NOT YET BACK IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OCCURRED TO ANY OTHER INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. IT WAS REPORTED THAT THE DEFECTIVE PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.