GRANUFLO DISSOLUTION TANK

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 (BMT) REPORTED TO TECHNICAL SUPPORT (TS) THAT A GRANUFLO DISSOLUTION TANK WOULD NOT DRAIN AND THERE WAS SMOKE FROM THE PUMP, AND THEY WERE REQUESTING A REPLACEMENT PUMP. ADDITIONAL INFORMATION OBTAINED VIA FOLLOW-UP WITH THE BMT CONFIRMED THERE WAS NO SPARKING, NOTHING WAS DAMAGED, AND THERE WERE NO VISIBLE SIGNS OF THERMAL DAMAGE FOUND ON ANY COMPONENTS. THERE WERE NO SMOKE ALARMS NOTED. THE MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND FAULT INTERRUPTER (GFI) OUTLET. PER BMT, THE MIXER REMAINS OUT OF SERVICE PENDING DELIVERY OF THE REPLACEMENT PUMP. IT WAS CONFIRMED THAT THIS DID NOT IMPACT ANY TREATMENTS. THE PUMP WAS AVAILABLE TO BE RETURNED.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT (TS) THAT A GRANUFLO DISSOLUTION TANK WOULD NOT DRAIN AND THERE WAS SMOKE FROM THE PUMP, AND THEY WERE REQUESTING A REPLACEMENT PUMP. ADDITIONAL INFORMATION OBTAINED VIA FOLLOW-UP WITH THE BMT CONFIRMED THERE WAS NO SPARKING, NOTHING WAS DAMAGED, AND THERE WERE NO VISIBLE SIGNS OF THERMAL DAMAGE FOUND ON ANY COMPONENTS. THERE WERE NO SMOKE ALARMS NOTED. THE MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND FAULT INTERRUPTER (GFI) OUTLET. PER BMT, THE MIXER REMAINS OUT OF SERVICE PENDING DELIVERY OF THE REPLACEMENT PUMP. IT WAS CONFIRMED THAT THIS DID NOT IMPACT ANY TREATMENTS. THE PUMP WAS AVAILABLE TO BE RETURNED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: THE RECIRCULATION MOTOR (PUMP) ASSEMBLY WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. EXTERIOR INSPECTION FOUND RUST AND DRIED RESIDUE ON THE ASSEMBLY. THE MOTOR/PUMP OPERATION TEST FAILED. AFTER CONNECTING THE MOTOR TO POWER, THE MOTOR MADE A HUM NOISE, BUT THE PUMP DID NOT FUNCTION. AFTER REMOVING THE PUMP ASSEMBLY FROM THE MOTOR, A CLICKING NOISE WAS HEARD WHEN TURNING THE MOTOR¿S DRIVE MAGNET BY HAND. THE NOISE WAS TRACED TO THE ARMATURE STACK MAKING CONTACT WITH WORN WINDING INSULATION. INTERNAL INSPECTION FOUND PIECES OF PLASTIC ON THE FRONT HOUSING AND ON THE IMPELLER ASSEMBLY. FRICTION DAMAGE WAS ALSO FOUND ON THE FRONT HOUSING. PIECES OF PLASTIC IN THE PUMP ASSEMBLY CAN IMPEDE PUMP OPERATION. THE FRICTION DAMAGE IS CAUSED BY RUNNING THE PUMP MOTOR ASSEMBLY WITHOUT WATER. THERMAL DAMAGE WAS NOT OBSERVED. THE RECIRCULATION MOTOR (PUMP) ASSEMBLY FUNCTION IS NOT ASSOCIATED WITH THE GRANUFLO¿S DRAIN CYCLES. 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 COMPONENT FAILURE. THE COMPONENT WAS RETURNED TO RETURN GOODS FOLLOWING THE INVESTIGATION.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT (TS) THAT A GRANUFLO DISSOLUTION TANK WOULD NOT DRAIN AND THERE WAS SMOKE FROM THE PUMP, AND THEY WERE REQUESTING A REPLACEMENT PUMP. ADDITIONAL INFORMATION OBTAINED VIA FOLLOW-UP WITH THE BMT CONFIRMED THERE WAS NO SPARKING, NOTHING WAS DAMAGED, AND THERE WERE NO VISIBLE SIGNS OF THERMAL DAMAGE FOUND ON ANY COMPONENTS. THERE WERE NO SMOKE ALARMS NOTED. THE MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND FAULT INTERRUPTER (GFI) OUTLET. PER BMT, THE MIXER REMAINS OUT OF SERVICE PENDING DELIVERY OF THE REPLACEMENT PUMP. IT WAS CONFIRMED THAT THIS DID NOT IMPACT ANY TREATMENTS. THE PUMP WAS AVAILABLE TO BE RETURNED.

Additional Manufacturer Narrative

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 FIELD SERVICE TECHNICIAN (FST). 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.