Description of Event or Problem · 0
PER THE MANUFACTURER INVESTIGATION; A PATIENT EXPERIENCED A MEDICAL CODE (PRESUMED MEDICAL EMERGENCY) APPROXIMATELY TWO (2) HOURS AFTER THE START OF HEMODIALYSIS THERAPY. THE SPECIFIC NATURE OF THE MEDICAL EMERGENCY WAS NOT REPORTED. THE EVENT OCCURRED DURING TREATMENT AND WAS REPORTED BY THE CUSTOMER TO B. BRAUN. NO MACHINE ALARMS OR TREATMENT IRREGULARITIES WERE REPORTED DURING THE SESSION. FOLLOWING THE EVENT, THE LOCAL BIOMED TEAM PERFORMED A TECHNICAL EVALUATION OF THE MACHINE. THE DEVICE HAD BEEN PROGRAMMED FOR A SODIUM CONCENTRATION OF 138 MILLIEQUIVALENTS PER LITER (MEQ/L), WHILE POST-EVENT TESTING MEASURED 142 MEQ/L. NO MACHINE MALFUNCTIONS, ABNORMAL ALARMS, OR TREATMENT IRREGULARITIES WERE IDENTIFIED. A MINOR DEVIATION FROM (B)(6) INTERNAL SPECIFICATION FOR SODIUM CONCENTRATION WAS NOTED. THE PATIENT ULTIMATELY CODED AND DIED. THE CUSTOMER EMPHASIZED THAT THE PATIENT HAD SIGNIFICANT PRE-EXISTING MEDICAL CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO PRODUCT-RELATED LIABILITY CONCERNS WERE IDENTIFIED BY THE CUSTOMER. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS WERE MADE AVAILABLE, INCLUDING MACHINE DATA RECORDS OR ADDITIONAL MEDICAL INFORMATION. THE HEMODIALYSIS MACHINE IN QUESTION WAS MANUFACTURED ON 11MARCH2020 AND OPERATED WITH SOFTWARE VERSION 9.1B. IN THIS SOFTWARE VERSION, THE DIALYSIS FLUID CONDITIONING SYSTEM IS CONDUCTIVITY-REGULATED, WITH A TOLERANCE OF ±0.2MS/CM. THE DEVICE IS EQUIPPED WITH TWO CONDUCTIVITY SENSORS: END-LF (CONTROLLER) AND END-LF S (SUPERVISOR), WHERE THE END-LF S FUNCTIONS AS THE PROTECTIVE SYSTEM. ITS LIMIT IS DEFINED AS ±5% OF THE SET CONDUCTIVITY VALUE. MACHINES RUNNING DIALOG+ SOFTWARE VERSION 9.XX CAN BE CONFIGURED TO DISPLAY VALUES IN MMOL/L INSTEAD OF MS/CM, ALTHOUGH INTERNAL CONTROL IS ALWAYS BASED ON CONDUCTIVITY IN MS/CM. CONVERSION BETWEEN THE DISPLAYED MMOL/L VALUES AND THE INTERNAL CONDUCTIVITY VALUES IS PERFORMED USING CONCENTRATE-SPECIFIC CONVERSION FACTORS. SODIUM VALUES REPORTED IN MEQ/L CORRESPOND NUMERICALLY TO MMOL/L, I.E., 1MEQ/L = 1MMOL/L. IN THIS CASE, THE MACHINE WAS SET TO A SODIUM CONCENTRATION OF 138MEQ/L, WHICH CORRESPONDS TO A ±5% PROTECTIVE LIMIT RANGE OF 131.1-144.9MMOL/L. POST-EVENT TESTING REPORTEDLY RESULTED IN A SODIUM VALUE OF 142MEQ/L. IT IS NOT SPECIFIED WHETHER THIS VALUE REFLECTS A SERUM SODIUM MEASUREMENT OR A DETERMINATION OF THE DIALYSATE SODIUM CONCENTRATION. THE MEASURED VALUE REMAINED WITHIN THE ±5% LIMIT, AND CONSEQUENTLY NO FINAL CONDUCTIVITY ALARM WOULD HAVE BEEN TRIGGERED DURING THERAPY. BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF IMPROPER FUNCTION OF THE PROTECTIVE SYSTEM. THE PROTECTIVE MECHANISMS REQUIRED UNDER IEC 60601-2-16 WERE IN PLACE. ACCORDING TO THE STANDARD, THE REPORTED DEVIATION IN CONDUCTIVITY DID NOT REACH A LEVEL THAT WOULD BE CONSIDERED CAPABLE OF CREATING A SAFETY HAZARD. THERE IS NO INDICATION OF A PRODUCT DEVIATION OR MALFUNCTION, AND NO EVIDENCE SUGGESTS THAT THE DIALYSIS MACHINE CONTRIBUTED TO THE PATIENT'S DEATH. NO PRODUCT RELATED LIABILITY CONCERNS WERE IDENTIFIED BY THE CUSTOMER AND THE CUSTOMER ALSO REPORTED THAT THE PATIENT HAD SIGNIFICANT UNDERLYING MEDICAL CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE EVENT. THEREFORE, THERE IS NO SUSPECTED ASSOCIATION BETWEEN THE PATIENT'S DEATH AND THE USE OF THE PRODUCT. BASED ON THE INVESTIGATION RESULTS, THE CASE WAS ASSESSED AS NOT REPORTABLE TO THE NATIONAL COMPETENT AUTHORITY.