GRANUFLO DISSOLUTION TANK

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND REVEALED RUST, CORROSION AND SALT BUILD UP ON THE MOTOR. THE MIXER MOTOR WAS PLUGGED INTO A POWER SOURCE AND MOTOR DID NOT TURN, BURNING SMELL WAS PRESENT. AN INTERNAL INSPECTION REVEALED RUST, CORROSION, SALT BUILD AND SCRATCHES ON THE STATOR CAUSED BY CORROSION BUILD UP OVER TIME CAUSING THE MOTOR TO SIZE UP. 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.

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 (BIOMED) AT A USER FACILITY REPORTED THAT A DRY ACID MIXER MOTOR WAS SMOKING AND STOPPED WORKING. THE MIXER IS CURRENTLY NON-OPERATIONAL. WHEN IT WAS TURNED ON, THE BREAKERS TRIPPED. THIS IS THE SECOND TIME THE MIXER MOTOR HAS SMOKED AND STOPPED WORKING. UPON FOLLOW UP, THE BIOMED CONFIRMED THE SMOKING AND REPORTED A BURNING SMELL. THERE WAS NO MELTING, SMOKE, SPARK, OR FLAME. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE BIOMED CONFIRMED THAT THE MACHINE HAS NOT HAD ANY PAST PROBLEMS AND THERE HAS ONLY BEEN ONE INCIDENT OF SMOKING.

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 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.