DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC
Report
- Report Number
- 3002879653-2015-00013
- Event Type
- Malfunction
- Date Received
- January 5, 2016
- Date of Event
- November 11, 2015
- Report Date
- December 14, 2015
- Manufacturer
- B. BRAUN AVITUM AG - MELSUNGEN
- Product Code
- FKJ
- PMA / PMN Number
- K963440
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
EXEMPTION NUMBER E2015012. B. BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN AVITUM AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN AVITUM INTERNAL REPORT (B)(4). IN A FOLLOW UP WITH THE FACILITY, THE REPORTER STATED THAT TEMS WAS NOT CALLED AND SALINE WAS NOT ADMINISTERED. PATIENT ONLY COMPLAINED OF MINOR CRAMPING. PATIENT WENT HOME AND REPORTED THAT THEY DID NOT HAVE ANY COMPLAINTS AFTER GOING HOME. THE INVESTIGATION IS ON-GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE EVALUATION RESULTS ARE AVAILABLE.
EXEMPTION NUMBER E2015012 B. BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN AVITUM AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN AVITUM INTERNAL REPORT (B)(4). CUSTOMER REPORTED THAT DURING A THERAPY ON THE DIALOG MACHINE SN (B)(6), AND EXCESS OF FLUID AMOUNTING TO 100 ML WAS REMOVED FROM A PATIENT. THE CUSTOMER TECHNICIAN FOUND A CRACKED BICARBONATE CONDUCTIVITY SENSOR (ITEM# 3456012A). HE BELIEVES THAT THIS DEFECT MIGHT BE RESPONSIBLE FOR THE OVER FILTRATION, BECAUSE THROUGH THE CRACK AIR IS ALLOWED TO ENTER THE SYSTEM. THE CONDUCTIVITY SENSOR WAS REPLACED BY THE CUSTOMER'S TECHNICIAN. AFTER A SUCCESSFUL MOCK THERAPY, THE DIALYSIS MACHINE PUT BACK INTO OPERATION. ALL INFORMATION ASSOCIATED WITH THIS EVENT WAS FORWARDED TO B. BRAUN AVITUM AG (MANUFACTURER) FOR FURTHER EVALUATION. ALSO SUBMITTED WAS THE REPLACED SENSOR FOR EVALUATION. BASED ON THEIR INVESTIGATION, THE MANUFACTURER CONFIRMED THAT THE COMPONENT HAD SOME CRACKS AT THE CONNECTION POINT TO THE DF-BLOCK. THE INVESTIGATION INDICATES THAT DURING THERAPY THERE IS NEGATIVE PRESSURE AT THE CONDUCTIVITY CELLS. SO A LEAKAGE AT THIS POINT LEADS TO AIR BEING SUCKED INTO THE FLUID SYSTEM OF THE DEVICE. AIR SUCKED INTO THE FLUID SYSTEM AT THIS POINT IS PUMPED THROUGH THE DIALYSIS FLUID SYSTEM UNTIL IT REACHES THE AIR SEPARATOR, WHERE IT IS ACCUMULATED. IF THE AIR SEPARATOR GETS FILLED WITH AIR, THE AIR IS SEPARATED BY OPENING THE AIR SEPARATOR VALVE VLA. THE OPENINGS OF VLA ARE COUNTED, AND AFTER THE 10TH OPENING OF THIS VALVE THE ALARM 1026 IS TRIGGERED AS MENTIONED: ALARM TEXT: "UF BALANCE? AIR LEAKAGE IN DIALYZ.COUPL." 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. AS DESCRIBED ABOVE, 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 SHOWING THIS FAILURE TYPE WERE INVESTIGATED. 64 OF THESE CELLS SHOWED AN UF DEVIATION BELOW 200 ML/H AND 13 ABOVE 200 ML/H AT A DIALYSIS FLUID FLOW OF 800 ML/MIN. THE MAXIMUM UF DEVIATION MEASURED IN THIS CASE WAS 488 ML/H. IN DIALOG MACHINES WITHOUT DF-FILTER THE AIR IS ALSO TRANSPORTED TO THE AIR SEPARATOR, WHERE IT ACCUMULATES AND IS RELEASED AS DESCRIBED ABOVE. SINCE THERE IS NO DF-FILTER, IN THESE DEVICES NO ACCUMULATING AIR MIGHT CAUSE AN EXCESS UF. THE AIR ACCUMULATED IN THE AIR SEPARATOR EXPANDS WHEN IT IS SEPARATED AND SUBSTITUTED WITH DIALYSIS FLUID FROM OUTSIDE THE BALANCE CIRCUIT. SO THE FLUID VOLUME IS BIGGER THAN THE VOLUME OF THE COMPRESSED AIR AND THE UF VOLUME IS DECREASED. THEREFORE, IN DEVICES WITHOUT DF-FILTER AIR ENTRY MIGHT LEAD TO A TOO LOW ULTRAFILTRATION ("INSUFFICIENT REMOVAL"). THIS MECHANISM OCCURS ALSO IN DEVICES WITH DF-FILTER BUT IS SUPERIMPOSED BY THE DESCRIBED CYCLICAL PRESSURE FLUCTUATIONS INSIDE THE DF-FILTER. THE AMOUNT OF INSUFFICIENT UF CAUSED BY THIS FAILURE TYPE IN DIALYSIS MACHINES WITHOUT DF-FILTER WAS DETERMINED IN THE ABOVE MENTIONED THEORETICAL WORST CASE SETTING. THE MAXIMUM UF DEVIATION IN THIS CASE WAS 250 ML/H AT A DIALYSIS FLUID FLOW OF 800 ML/MIN. THE RESPECTIVE ALARM WAS TRIGGERED FOR THE FIRST TIME AFTER 13 MIN. TO FURTHER INVESTIGATE THE UF DEVIATION 24 CONDUCTIVITY CELLS RETURNED FROM THE MARKET WERE TESTED. THREE OF THESE CONDUCTIVITY CELLS SHOWED A DEVIATION BETWEEN 100 TO 200 ML/H WITH A MAXIMUM AT 148 ML/H, THE OTHER CONDUCTIVITY CELLS SHOWED LOWER OR NO UF DEVIATION. THE TESTS SHOWED THAT THE UF DEVIATIONS DECREASED WITH DECREASING DIALYSIS FLUID FLOW. THEY ALSO IMPLY THAT THE CRACKS AT THE CONDUCTIVITY CELLS DEVELOP AND INCREASE WITH TIME DURING CONTINUOUS USE OF THE DEVICE. WITH AN INCREASING LEAKAGE, THE AMOUNT OF AIR SUCKED INTO THE DIALYSIS FLUID SYSTEM INCREASES AND THE FREQUENCY OF THE OPENING OF THE VLA VALVE. THIS MEANS THAT THE ABOVE DESCRIBED ALARM STARTS TO OCCUR FIRST TOWARDS THE END OF A THERAPY AND OCCURS EARLIER AND EARLIER WITH THE GROWTH OF THE CRACK. IF THE LEAKAGE MIGHT APPROACH THE MAXIMUM, THE ALARM IS TRIGGERED EARLY IN THERAPY AND MORE FREQUENTLY. IF THE MAXIMUM IS REACHED, FOLLOW-UP ALARMS WILL STOP THE PREPARATION OR THERAPY PHASE. ROOT CAUSE: THE PRINCIPLE CAUSE OF FAILURE OF THE PRODUCT IS DUE TO VARIATION IN MOLDING PARAMETERS OF THE FLANGES UTILIZED IN THE CONSTRUCTION OF THE CONDUCTIVITY SENSORS. DUE TO THE VARIATION IN MOLDING PARAMETERS, THERE IS POTENTIAL FOR THERMAL AND MECHANICAL STRESSES DURING NORMAL OPERATION TO INDUCE CRACKS IN THE CONDUCTIVITY SENSORS WHICH CAUSES THE INGRESS OF AIR INTO THE DIALYSIS FLUID. CORRECTION: B. BRAUN AVITUM AG (MANUFACTURER) AND B. BRAUN MEDICAL INC (IMPORTER) HAVE INITIATED AN URGENT MEDICAL DEVICE CORRECTION (RECALL) ON APRIL 1, 2016. ACTION TAKEN TO PREVENT RECURRENCE OF PROBLEM: B. BRAUN AVITUM AG (MANUFACTURER) HAS INITIATED CAPA2-2016-002. B. BRAUN AVITUM US (IMPORTER) HAS INITIATED CAPA2016-004-PFG. IF ADDITIONAL PERTINENT BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.
EXEMPTION NUMBER E2015012. B. BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN AVITUM AG (MANUFACTURER) THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN AVITUM INTERNAL REPORT (B)(4). IT WAS REPORTED THAT DURING A THERAPY WITH THE ABOVE-MENTIONED DIALOG+ DIALYSIS MACHINE, AN EXCESS OF FLUID AMOUNTING TO 100 ML WAS REMOVED FROM THE PATIENT. THE CUSTOMER'S TECHNICIAN FOUND A CRACKED BICARBONATE CONDUCTIVITY SENSOR. HE BELIEVES THAT THIS DEFECT MIGHT BE RESPONSIBLE FOR THE OVERFILTRATION, BECAUSE THROUGH THE CRACK AIR GET PULLED INT THE MACHINE. THE CONDUCTIVITY SENSOR WAS REPLACED BY THE CUSTOMER'S TECHNICIAN. AFTER A SUCCESSFUL MOCK THERAPY, THE DIALYSIS MACHINE WAS PUT BACK INTO OPERATION. ALL AVAILABLE INFORMATION WAS FORWARDED TO THE DEVICE MANUFACTURER FOR FURTHER EVALUATION. THEIR REPORT STATES THAT THE RETURNED BICARBONATE CONDUCTIVITY SENSOR SHOWED CRACKS AT ITS CONNECTION TO THE DIALYSIS FLUID BLOCK. DURING THERAPY THERE IS A NEGATIV PRESSURE AT THE CONDUCTIVITY CELL. IN CASE OF A LEAKAGE, AIR IS SUCKED INTO THE FLUID SYSTEM OF THE DIALYSIS MACHINE. THE AIR ACCUMULATES IN THE AIR SEPARATOR. WHEN THE AIR SEPARATOR IS FILLED WITH AIR, THE AIR IS REMOVED FROM THE FLUID SYSTEM BY OPENING THE AIR SEPARATOR VALVE (VLA). THEREAFTER, THE AIR SEPARATOR IS FILLED WITH FLUID COMING FROM THE OUTSIDE OF THE BALANCE CIRCUIT. CONSEQUENTLY, THE AIR ACCUMULATED IN THE FLUID CIRCUIT DOES NOT COMPROMISE THE ACCURACY OF THE ULTRAFILTRATION. AFTER THE 10TH OPENING OF THE VALVE VLA, THE DIALOG+ DIALYSIS MACHINE TRIGGERS THE ALARM "UF BALANCE? AIR LEAKAGE IN DIALYZ.COUPL." MAKING THE OPERATOR AWARE THAT HERE IS AIR IN THE SYSTEM. SINCE THE CUSTOMER DOES NOT REMEMBER AN ALARM, IT IS REASONABLY CONCLUDED THAT THE VLA VALVE HAD OPENED LESS THAN 10 TIMES. COMPREHENSIVE TESTS IN THE LABORATORY PROVED THAT AIR ENTRY INTO THE FLUID CIRCUIT DUE TO A CRACK IN A CONDUCTIVITY SENSOR HAS NO IMPACT ON THE BALANCE ACCURACY AND DOES NOT LEAD TO OVERFILTRATION. AS OUTLINED BEFORE, A CRACK IN THE CONDUCTIVITY SENSOR DOES NOT LEAD TO AN OVERFILTRATION. IN ADDITION, THE REPORTED AMOUNT OF 100 ML IS WITHIN THE SPECIFIED TOLERANCE OF THE DIALOG+ DIALYSIS MACHINE AS OUTLINED IN CHAPTER 15 "TECHNICAL DATA" OF THE INSTRUCTIONS FOR USE OF THE DIALOG+ DIALYSIS MACHINE. THIS AMOUNT DOES NOT PRESENT A RISK TO THE PATIENT AND CAN NOT BE MADE RESPONSIBLE FOR THE MINOR CRAMPING OF THE PATIENT DURING THE THERAPY IN QUESTION. ALTHOUGH A CRACK IN A CONDUCTIVITY SENSOR DOES NOT COMPROMISE THE BALANCE ACCURACY OF THE DIALOG+ DIALYSIS MACHINE, CAPA 2-2016-002 WAS INITIATED TO INVESTIGATE THE CAUSE OF THE CRACKS AND TO DEFINE MEASURES TO AVOID THIS FAILURE IN THE FUTURE, BECAUSE THERE WAS AN ACCUMULATION OF THIS FAILURE TYPE. CORRECTION: CHANGE FROM - SECTION D1 - BRAND NAME: DIALOG A + HE/BIC CHANGE FROM - SECTION D4 CATALOG #: 710200L CHANGE TO - SECTION D1 - BRAND NAME: DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC CHANGE TO - SECTION D4 CATALOG #: 710200S
AS REPORTED BY THE USER FACILITY: OVER FILTRATION OF A PATIENT AS REPORTED BY THE STAFF; THE AMOUNT OF FLUID REMOVED IS NOT KNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3956 | DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC | HEMODIALYSIS SYSTEM | FKJ | B. BRAUN AVITUM AG - MELSUNGEN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |