GRANUFLO II, ASSY TO SHIP

Description of Event or Problem

PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. INSPECTION OF THE GRANUFLO II FOUND EXTENSIVE RUST ON THE FRAME, A LARGE SALT DEPOSIT AT THE PUMP INTAKE CONNECTION, RUST ON THE PUMP MOTOR, RUSTED HOSE CLAMPS, CORROSION ON THE TRANSFER VALVE CABLE CONNECTORS, AND RUST ON JET VALVE 2. DURING TESTING THE GRANULO II WOULD NOT FILL DURING FILL, RINSE CYCLE. TROUBLESHOOTING DETERMINED THAT THE DISPLAY (CONTROL) BOARD WAS NOT RECEIVING 24VDC FROM THE POWER SUPPLY DUE TO OPEN FUSES IN THE POWER SUPPLY. AFTER REPLACING THE POWER SUPPLY, 24VDC WAS RESTORED TO THE DISPLAY (CONTROL) BOARD. DURING SUBSEQUENT TESTING THE GRANUFLO II WOULD NOT FILL IN FILL, RINSE CYCLE, AND WATER WOULD NOT CIRCULATE IN THE TANK DURING RECIRCULATION, RINSE CYCLE. AFTER FILLING THE TANK MANUALLY WITH WATER, THE GRANUFLO II WAS STEPPED TO RECIRCULATION, RINSE CYCLE. THOUGH WATER DID NOT CIRCULATE IN THE TANK, THE PUMP MOTOR RAN. NO SMOKE OR BURNING SMELL OCCURRED WHILE THE RECIRCULATION PUMP RAN. AN INSPECTION OF THE PUMP HEAD FOUND NO ANOMALIES. IT WAS DETERMINED THAT JET VALVE 2 WAS SHORTED. THE SHORTED VALVE CAUSED 1VDC TO BE OUTPUT TO THE FILL VALVE AND JET VALVES DURING FILL AND RECIRCULATION MODES IN A RINSE CYCLE. 24VDC IS THE EXPECTED OUTPUT TO THE VALVES. JET VALVE 2 WAS DISCONNECTED FROM THE GRANUFLO II, 24VDC WAS OUTPUT TO THE FILL AND JET VALVES DURING FILL AND RECIRCULATION MODES IN A RINSE CYCLE. THE DISPLAY (CONTROL) BOARD WAS TESTED ON A TEST FIXTURE AND PASSED ALL TESTS. INSPECTION OF JET VALVE 2 FOUND CORROSION AND CHARRING ON THE VALVE CONNECTOR AND CABLE CONNECTOR. CORROSION WAS FOUND ON THE GROUND PINS OF THE CONNECTORS. THE WIRES WITHIN THE JET VALVE 2 CABLE WERE FOUND TO HAVE PROPER CONTINUITY. 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.

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 BIOMEDICAL TECHNICIAN REPORTED A FRESENIUS GRANUFLO II MIXER THAT GAVE OFF SMOKE AND A BURNING SMELL AFTER IT WAS POWERED ON. IT WAS CONFIRMED THAT THERE WAS NO VISIBLE FLAME, AND CONFIRMED THAT NO SMOKE ALARMS AT THE FACILITY WENT OFF. IT WAS CONFIRMED THERE WAS NO PATIENT INVOLVEMENT, AND CONFIRMED THAT THE MIXER WAS BEING REPLACED WITH A NEW UNIT RATHER THAN BEING REPAIRED.

Additional Manufacturer Narrative

CORRECTION: DEVICE CODE CHANGED TO SMOKE. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.