NO PARTS WERE RETURNED TO THE MANUFACTURER UNDER FAILURE ANALYSIS FOR PHYSICAL EVALUATION. THE 2008K@HOME HEMODIALYSIS (HD) MACHINE WAS EVALUATED ON-SITE BY A FRESENIUS MEDICAL CARE (B)(4) REGIONAL SERVICE REPRESENTATIVE (RSR). THE RSR REPLACED THE ACTUATOR BOARD WITH A NEWER VERSION, AND THEN PERFORMED A SIMULATED TREATMENT. FUNCTIONAL TESTING PERFORMED BY THE RSR CONFIRMED THAT THE SYSTEM WAS OPERATING PROPERLY. THE PATIENT WAS ABLE TO CONTINUE THEIR REGULARLY SCHEDULED HOME HEMODIALYSIS (HHD) TREATMENTS USING THIS MACHINE WITHOUT A RECURRENCE OF THE REPORTED EVENT. 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 DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH 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 ABLE TO CONFIRM THE FAILURE MODE. THE FMCC RSR REPLACED THE ACTUATOR BOARD WITH A NEWER VERSION TO RESOLVE THE ISSUE. THEREFORE, THE COMPLAINT HAS BEEN DEEMED CONFIRMED.
D
Patient 1
A HOME HEMODIALYSIS (HHD) PATIENT REPORTED TO A FRESENIUS MEDICAL CARE (B)(4) REGIONAL SERVICE REPRESENTATIVE (RSR) THAT THE 2008K@HOME HD MACHINE GENERATED A "DIAL VALVE ERROR 1 ALARM" APPROXIMATELY ONE HOUR AFTER THE HD TREATMENT WAS INITIATED. FOLLOWING THE ALARM, THE PATIENT DISCONNECTED FROM THE MACHINE WITHOUT RINSING BACK THE BLOOD WITHIN THE EXTRACORPOREAL CIRCUIT AS PER PROCEDURE. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING APPROXIMATELY 100 MILLILITERS (ML). NO VISIBLE ISSUES OR DEFECTS WERE IDENTIFIED WITH THE BLOODLINE OR DIALYZER PRODUCTS. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT ENDED THE HHD TREATMENT TO ALLOW FOR THE ON-SITE EVALUATION OF THE SYSTEM BY A RSR. FOLLOWING THE EVENT, THE RSR PERFORMED AN ON-SITE EVALUATION OF THE UNIT. THE RSR CHECKED VALVES 24, 25, AND 26 AND CHECKED THE CONNECTION TO THE GROUND; ALL CHECKS WERE SATISFACTORY. THE RSR REPLACED THE ACTUATOR BOARD WITH A NEWER VERSION, AND THEN PERFORMED A SIMULATED TREATMENT. FUNCTIONAL TESTING PERFORMED BY THE RSR CONFIRMED THAT THE SYSTEM WAS OPERATING PROPERLY. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EXAMINATION. THE PATIENT WAS ABLE TO CONTINUE THEIR REGULARLY SCHEDULED HD TREATMENTS USING THIS MACHINE. NO SCHEDULED TREATMENTS WERE MISSED FOLLOWING THIS EVENT, AND NO ADDITIONAL, UNSCHEDULED HD THERAPY WAS PERFORMED AS A RESULT OF THIS INCIDENT.