GRANUFLO DISSOLUTION TANK

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT THEY OBSERVED ARCING AND SMOKE COME FROM THE CONTROL BOX OF A GRANUFLO MIXER. THE BIOMED WAS REQUESTING THE PART NUMBER FOR THE CONTROL CONSOLE, WHICH TS STATED WAS NO LONGER AVAILABLE AS A SPARE PART. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE BIOMED. THE ORIGINAL ISSUE WAS THAT THE MIXER WAS POWERING DOWN WHEN ATTEMPTING TO MOVE IT INTO A FILL PHASE. THE BIOMED TRIED UNPLUGGING THE POWER CORD AND POWER CYCLING THE DEVICE MULTIPLE TIMES, BUT TO NO AVAIL. NEXT THEY TRIED PLUGGING THE MIXER INTO A DIFFERENT OUTLET. AFTER POWERING IT BACK ON AND THEN PRESSING "FILL", AN ARC WAS SEEN COMING FROM UNDERNEATH THE CONTROL BOX ALONG WITH A SMALL AMOUNT OF SMOKE. THE BIOMED IMMEDIATELY POWERED OFF THE MIXER AND UNPLUGGED IT. THE BIOMED PROMPTLY OPENED A NEARBY DOOR TO AIR OUT AND VENTILATE THE ROOM. THE SMOKE DETECTORS DID NOT GO OFF. THERE WAS NO INJURY/HARM DUE TO THE EVENTS, AND NO PATIENT INVOLVEMENT. AFTER FURTHER INVESTIGATION, THE BIOMED REALIZED THAT THE SOLENOID FILL VALVE HAD CAUGHT FIRE SENDING A SURGE UP THE CABLE TO THE CONTROL BOX. THE BIOMED SAID A HOLE WAS BURNED THROUGH THE SIDE OF THE SOLENOID VALVE. THE BIOMED WAS ABLE TO FIX THE MACHINE BY REPLACING THE SOLENOID FILL VALVE, THE CABLE, AND THE CONTROL BOX. THEY TOOK THE SPARE PARTS FROM A MIXER THAT HAD BEEN TAKEN OUT OF SERVICE AT A NEARBY CLINIC. THE BIOMED SAID THE SOLENOID FILL VALVE WAS THE ORIGINAL PART ON THE GRANUFLO MIXER, AND THAT THE MIXER WAS QUITE OLD. THE DAMAGED PARTS WERE DISCARDED; NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE MIXER WAS CONFIRMED TO BE FULLY OPERATIONAL AGAIN AND HAS NOT EXPERIENCED ANY FURTHER ISSUES. A PHOTO OF THE DAMAGED SOLENOID FILL VALVE WAS PROVIDED FOR REVIEW.

Additional Manufacturer Narrative

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