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Patient 1
EVENT #1: (B)(4).. CUSTOMER ORIGINALLY REPORTED THAT DURING THERAPY WITH THE DIALOG+ DIALYSIS MACHINE ((B)(4)), TWO PATIENTS HAD AN EXCESS ULTRAFILTRATION OF APPROXIMATELY 1.5 KG. THE PATIENTS EXPERIENCED CRAMPS AND WERE ADMINISTERED WITH SALINE. CUSTOMER BIOMED FURTHER INDICATED THAT HE RAN A MOCK THERAPY, WHICH DID NOT SHOW ANY DEVIATIONS RELATED TO ULTRAFILTRATION. AFTER A FOLLOW UP CALL WITH THE FACILITY TO REQUEST ADDITIONAL INFORMATION ABOUT THE INCIDENT, THE CUSTOMER BIOMED INDICATED THAT ONE PATIENT (PATIENT 1) HAD A CRAMPING EPISODE, BUT THE PATIENT'S TARGET WEIGHT HAD JUST BEEN LOWERED AND THERE WERE NO ISSUES BEFORE OR AFTER THAT EVENT. BASED ON THE BIOMED'S REPORT, IT IS BELIEVED THAT THE INCIDENT WAS RELATED TO A PATIENT WEIGHING ISSUE, WHICH WAS BEING ADDRESSED WITH THE NURSING TEAM. A B. BRAUN TECHNICIAN ALSO VISITED YOUR FACILITY TO SERVICE THE MACHINE. DURING THIS INSPECTION HE FOUND A BICARBONATE CONDUCTIVITY SENSOR WITH A HAIRLINE CRACK IN THE FLANGE WHICH CONNECTS IT TO THE DIALYSIS FLUID BLOCK. THE SENSOR WAS REPLACED, ALL APPLICABLE CHECKS WERE COMPLETED AND THE MACHINE WAS RELEASED FOR SERVICE. ALL INFORMATION ASSOCIATED WITH THIS EVENT WAS FORWARDED TO B. BRAUN (B)(4) (MANUFACTURER) FOR FURTHER EVALUATION. ALSO SUBMITTED FOR EVALUATION WAS THE REPLACED SENSOR AND THE MACHINE TREND FILE. BASED ON THEIR INVESTIGATION, THE MANUFACTURER CONFIRMED THAT THE DATA SHOWED THAT DURING THE THERAPY THE ALARM "UF BALANCE? AIR LEAKAGE IN DIALYZ.COUPL." (ALARM CODE 1026) WAS TRIGGERED. THE ALARM WAS ACKNOWLEDGED BY THE USER AND THE THERAPY WAS CONTINUED. THE TREND DATA EVALUATION CORRESPONDS TO THE HAIRLINE CRACK FOUND IN THE FLANGE OF THE CONDUCTIVITY SENSOR. IN CASE OF A CRACK, AIR LEAKS INTO FLUID SYSTEM OF THE MACHINE DUE TO THE NEGATIVE PRESSURE IN THIS AREA. THE AIR IS COLLECTED IN THE AIR SEPARATOR. IF THE AIR SEPARATOR IS FILLED, THE AIR IS RELEASED BY OPENING THE VALVE VLA AND REPLACED BY FLUID FROM OUTSIDE THE BALANCE CIRCUIT. AFTER THE 10TH OPENING OF THE VALVE, THE ALARM "UF BALANCE? AIR LEAKAGE IN DIALYZ.COUPL." (ALARM CODE 1026) IS TRIGGERED AS DESCRIBED. AS PART OF THE INVESTIGATION, THE MANUFACTURER RAN THREE MOCK THERAPIES WITH THE RETURNED CONDUCTIVITY SENSOR WITH AN ULTRAFILTRATION VOLUME SET AT 1000 ML. THE ACTUAL ULTRAFILTRATION RESULTS WERE 991 TO 1028 ML, WHICH IS WELL WITHIN TOLERANCE. THE MANUFACTURER CONCLUDES THAT BASED ON THE RESULTS OF THE MOCK THERAPIES PERFORMED BY CUSTOMER BIOMED AND THE B. BRAUN TECHNICIAN, THE INCIDENT OF ULTRAFILTRATION AND THE PATIENT'S CRAMP EPISODE, IS INDEPENDENT FROM THE HAIRLINE CRACK FOUND IN THE CONDUCTIVITY SENSOR. FURTHERMORE, THE ENTIRE CASE WAS REVIEWED BY A NEPHROLOGIST AND BASED ON HIS ASSESSMENT, THE CRAMPING OF THE PATIENT IS ATTRIBUTED TO THE LOWERED DRY WEIGHT, WHICH WAS CONFIRMED BY THE FACILITY BIOMED. THE REPORTED ULTRAFILTRATION DEVIATIONS CAN BE ATTRIBUTED TO FACTORS INDEPENDENT FROM DIALYSIS AS FOR EXAMPLE WEIGHING ERRORS, WHICH WAS ALSO CONFIRMED BY THE FACILITY BIOMED AS A POTENTIAL CAUSE. ALTHOUGH, THE INCIDENT IN THIS CASE DOES NOT APPEAR TO HAVE BEEN CAUSED BY THE CRACKED CONDUCTIVITY SENSOR, THE MANUFACTURER HAS INITIATED A RECALL ON THE DIALOG MACHINE RELATED TO CRACKS IN THE CONDUCTIVITY SENSORS, WHICH CAN POTENTIALLY CAUSE UF DEVIATIONS IN PATIENT THERAPY. AS A RESULT OF OTHER REPORTS ASSOCIATED WITH UF DEVIATIONS, THE MANUFACTURER DISCOVERED THAT A LIMITED NUMBER OF FLANGES ASSEMBLED INTO BICARBONATE AND END CONDUCTIVITY CELLS SHOWED HAIRLINE CRACKS. THE CONDUCTIVITY SENSORS ARE UTILIZED IN AN AREA OF THE DIALYSIS FLUID SYSTEM WHICH IS UNDER NEGATIVE PRESSURE. THE NEGATIVE PRESSURE ALLOWS AIR TO BE SUCKED INTO THE DIALYSIS FLUID. THE AIR COLLECTS IN AN AIR SEPARATOR WHICH FORMS PART OF THE DIALYSIS FLUID SYSTEM. WHEN THE AIR SEPARATOR IS FILLED, THE AIR SEPARATOR VALVE (VLA) OPENS AND THE AIR IS PURGED AND REPLACED BY DIALYSIS FLUID FROM OUTSIDE THE BALANCE CIRCUIT. THE LEAKAGE HAS DIFFERENT CONSEQUENCES DEPENDANT UPON WHETHER OR NOT THE DIALOG+ HEMODIALYSIS MACHINE IS EQUIPPED WITH A DF-FILTER OR NOT. IN DIALOG MACHINES WITH DF-FILTER (OPTION DF-FILTER, HDF ONLINE MACHINES) THE AIR PASSES THIS FILTER ON ITS WAY TO THE AIR SEPARATOR. SINCE AIR BLOCKS THE FILTER IT IS FLUSHED OUT DURING CYCLIC FILTER RINSING, COLLECTED IN THE AIR SEPARATOR AND FLUSHED OUT AS DESCRIBED. CONTINUOUS AIR ENTRY DUE TO THE LEAKAGE OF THE CONDUCTIVITY CELLS CAN LEAD TO CYCLICAL PRESSURE FLUCTUATIONS DUE TO EXCESS AIR INSIDE THE DF-FILTER, THUS BLOCKING IT. THIS MIGHT LEAD TO AN EXCESS UF FOR THE PATIENT ("EXCESSIVE REMOVAL"). THE MAXIMUM POSSIBLE AMOUNT OF THE EXCESS UF (THEORETICAL WORST CASE) CAUSED BY THIS FAILURE TYPE WAS DETERMINED IN A LABORATORY SETTING ARTIFICIALLY PRODUCING THE MAXIMUM LEAKAGE AT WHICH THE DIALYSIS MACHINE CAN BE PUT IN THERAPY. AT A DIALYSIS FLOW OF 800 ML/MIN, THE UF DEVIATION WAS 636 ML/H WITH THE ALARM TRIGGERED AFTER 55 MIN OF THERAPY. IN ADDITION, 77 CONDUCTIVITY CELLS RETURNED FROM THE MARKET AND SHOWIN...