Additional Manufacturer Narrative · 1
THE CUSTOMER HAS NOT HAD ANY PROBLEMS WITH THE PRISMAFLEX MACHINES PRIOR TO THIS INCIDENT. NO PT INJURY WAS REPORTED AS A RESULT OF THIS INCIDENT. THE PT DIED SEVERAL DAYS LATER AS A RESULT OF OTHER NON-RELATED COMPLICATIONS AND THE PT'S MEDICAL RECORDS ARE NOT AVAILABLE. THE GAMBRO TECHNICAL SVCS (GTS) REP EVALUATED THE MACHINE AND FOUND ALL SCALES HAD BEEN CALIBRATED WITH THE "A AND C" WEIGHTS AND NOT THE "A AND B" WEIGHTS. ALSO FOUND THE EFFLUENT SCALE WAS DRIFTING NEGATIVE AND POSITIVE OVER 100 GRAMS. THE SCALE WOULD NOT ZERO AFTER IT WAS OPENED AND CLOSED. THE GTS REP REPLACED, CALIBRATED, AND VERIFIED THE EFFLUENT SCALE, AND RAN A PT SIMULATION RUN WITH NO PROBLEMS. THE MACHINE WAS TESTED AND RELEASED FOR USE. ON 03 AUGUST 2006, GAMBRO LUNDIA AB, VOLUNTARILY ISSUED AN ADVISORY NOTICE TO PROVIDE THE DETAILED CALIBRATION AND SPARE PARTS INSTRUCTIONS NECESSARY TO REDUCE THE POSSIBILITY OF INCORRECT OPERATION OF THE GAMBRO PRISMAFLEX SYS. THE PERMANENT CORRECTIVE ACTION CONSISTS OF A REVISION TO THE PRISMAFLEX SVC MANUAL WITH THE REVISED CALIBRATION AND SPARE PARTS INSTRUCTIONS. THE FDA WAS NOTIFIED THROUGH A REPORT OF FIELD CORRECTION DATED 08 AUGUST 2006. NO ILLNESS, INJURIES OR REQUIRED MEDICAL INTERVENTION WERE REPORTED DUE TO SCALE CALIBRATION ERRORS. NO FURTHER ACTIONS WILL BE TAKEN RELATING TO THIS INCIDENT AND THIS COMPLAINT WILL BE CLOSED. GAMBRO RENAL PRODS WILL CONTINUE TO MONITOR THIS ISSUE FOR TRENDS AS PART OF THE COMPLAINT AND CORRECTIVE ACTION SYS.