GRANUFLO DISSOLUTION TANK

Additional Manufacturer Narrative

CORRECTION: D5, G2 HEALTH PROFESSIONAL (CHANGED FROM "YES" TO "NO").

Description of Event or Problem

A BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS TECHNICAL SERVICE (TS) THAT THE GRANUFLO DISSOLUTION TANK WAS CLEANED AND AFTERWARD THE TRANSFER PUMP WAS SMOKING AND WAS CAUSING THE GFCI TO TRIP. THE BMT REPORTED WHEN TRYING TO RECIRCULATE THE PUMP/MOTOR IS STILL SMOKING AND HAS A SMELL OF SMOKE/BURNT SCENT. THE BMT WAS ADVISED TO CHECK THE WIRING TO THE DRAIN VALVE, REPLACE THE DRAIN VALVE ASSEMBLY AND TRANSFER PUMP/MOTOR ASSEMBLY. UPON FOLLOW-UP WITH THE BMT, IT WAS CONFIRMED THAT SMOKE AND A SMELL WERE DISCOVERED AFTER CLEANING OF THE MIXER. THERE WERE NO SMOKE ALARMS THAT WENT OFF AS THE SMOKING WAS NOT THAT BAD. THE MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND FAULT INTERRUPTER OUTLET. THERE WAS NO SPARKING, NOTHING APPEARED DAMAGED, AND THERE WERE NO SIGNS OF ANYTHING BURNT. NO ONE WAS HARMED DURING THE INCIDENT, AND THERE WAS NO REPORTED PATIENT INVOLVEMENT. TO RESOLVE THE REPORTED ISSUE, A NEW DRAIN VALVE ASSEMBLY AND TRANSFER PUMP/MOTOR ASSEMBLY WERE INSTALLED AND WAS REPORTED TO BE FUNCTIONING PERFECTLY. THE OLD NEW DRAIN VALVE ASSEMBLY AND TRANSFER PUMP/MOTOR ASSEMBLY WAS SAID TO BE DISCARDED AND WAS NO LONGER AVAILABLE FOR MANUFACTURER EVALUATION.

Description of Event or Problem

A BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS TECHNICAL SERVICE (TS) THAT THE GRANUFLO DISSOLUTION TANK WAS CLEANED AND AFTERWARD THE TRANSFER PUMP WAS SMOKING AND WAS CAUSING THE GFCI TO TRIP. THE BMT REPORTED WHEN TRYING TO RECIRCULATE THE PUMP/MOTOR IS STILL SMOKING AND HAS A SMELL OF SMOKE/BURNT SCENT. THE BMT WAS ADVISED TO CHECK THE WIRING TO THE DRAIN VALVE, REPLACE THE DRAIN VALVE ASSEMBLY AND TRANSFER PUMP/MOTOR ASSEMBLY. UPON FOLLOW-UP WITH THE BMT, IT WAS CONFIRMED THAT SMOKE AND A SMELL WERE DISCOVERED AFTER CLEANING OF THE MIXER. THERE WERE NO SMOKE ALARMS THAT WENT OFF AS THE SMOKING WAS NOT THAT BAD. THE MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND FAULT INTERRUPTER OUTLET. THERE WAS NO SPARKING, NOTHING APPEARED DAMAGED, AND THERE WERE NO SIGNS OF ANYTHING BURNT. NO ONE WAS HARMED DURING THE INCIDENT, AND THERE WAS NO REPORTED PATIENT INVOLVEMENT. TO RESOLVE THE REPORTED ISSUE, A NEW DRAIN VALVE ASSEMBLY AND TRANSFER PUMP/MOTOR ASSEMBLY WERE INSTALLED AND WAS REPORTED TO BE FUNCTIONING PERFECTLY. THE OLD NEW DRAIN VALVE ASSEMBLY AND TRANSFER PUMP/MOTOR ASSEMBLY WAS SAID TO BE DISCARDED AND WAS NO LONGER AVAILABLE FOR MANUFACTURER EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: 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.

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 BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS TECHNICAL SERVICE (TS) THAT THE GRANUFLO DISSOLUTION TANK WAS CLEANED AND AFTERWARD THE TRANSFER PUMP WAS SMOKING AND WAS CAUSING THE GFCI TO TRIP. THE BMT REPORTED WHEN TRYING TO RECIRCULATE THE PUMP/MOTOR IS STILL SMOKING AND HAS A SMELL OF SMOKE/BURNT SCENT. THE BMT WAS ADVISED TO CHECK THE WIRING TO THE DRAIN VALVE, REPLACE THE DRAIN VALVE ASSEMBLY AND TRANSFER PUMP/MOTOR ASSEMBLY. UPON FOLLOW-UP WITH THE BMT, IT WAS CONFIRMED THAT SMOKE AND A SMELL WERE DISCOVERED AFTER CLEANING OF THE MIXER. THERE WERE NO SMOKE ALARMS THAT WENT OFF AS THE SMOKING WAS NOT THAT BAD. THE MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND FAULT INTERRUPTER OUTLET. THERE WAS NO SPARKING, NOTHING APPEARED DAMAGED, AND THERE WERE NO SIGNS OF ANYTHING BURNT. NO ONE WAS HARMED DURING THE INCIDENT, AND THERE WAS NO REPORTED PATIENT INVOLVEMENT. TO RESOLVE THE REPORTED ISSUE, A NEW DRAIN VALVE ASSEMBLY AND TRANSFER PUMP/MOTOR ASSEMBLY WERE INSTALLED AND WAS REPORTED TO BE FUNCTIONING PERFECTLY. THE OLD NEW DRAIN VALVE ASSEMBLY AND TRANSFER PUMP/MOTOR ASSEMBLY WAS SAID TO BE DISCARDED AND WAS NO LONGER AVAILABLE FOR MANUFACTURER EVALUATION.