BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALOG A +INCL. BIC

    MDR report key: 6569436 · Received May 16, 2017

    Report

    Report Number
    3002879653-2017-00011
    Event Type
    Malfunction
    Date Received
    May 16, 2017
    Report Date
    April 18, 2017
    Manufacturer
    B.BRAUN AVITUM AG
    Product Code
    FKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    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), EVENT #7. INITIAL INFORMATION WAS RECEIVED FROM THE DISTRIBUTOR IN BOLIVIA. THE MACHINE TREND FILE AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FACILITY AND THE INVESTIGATION IS ON-GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE EVALUATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 0

    EVENT #7 AS REPORTED BY THE USER FACILITY IN BOLIVIA: ULTRAFILTRATION (UF) DEVIATION IN DIALYSIS MACHINE DIALOG+ WITHOUT RELATED ALARMS. THE ULTRAFILTRATION WAS HIGHER THAN PROGRAMMED. THE PATIENT DEVELOPED HYPOTENSION AND CRAMPS DURING DIALYSIS. THE THERAPY WAS TERMINATED AFTER 3 HOURS.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2015012. B. BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT (B)(4). THE ANALYSIS OF THE TREND DATA RECORDS OF THE COMPLAINED DIALOG+ DIALYSIS MACHINE SHOWED IN SOME CASES THAT THE DIALYSATE OUTLET PRESSURE (PDA) OSCILLATED WITH THE MOVEMENT OF THE BALANCE CHAMBER MEMBRANE. THIS INDICATED THAT ONE OF THE BALANCE CHAMBER VALVES DID NOT CORRECTLY CLOSE. THE INVESTIGATION OF THE DIALOG+ DIALYSIS MACHINE BY A B. BRAUN (B)(4) TECHNICIAN ON SITE CONFIRMED THE OSCILLATION OF THE PDA PRESSURE AS WELL AS THE BALANCE DEVIATION. IN THE COURSE OF THIS SERVICE CALL, ALL BALANCE CHAMBER VALVES WERE EXCHANGED AND RETURNED FOR INVESTIGATION. THEREAFTER, THE DIALOG+ OPERATED AGAIN AS INTENDED. THE INVESTIGATION OF THE RETURNED BALANCE CHAMBER VALVES SHOWED THAT A SLIVER FLOATING IN ONE BALANCE CHAMBER HAD SLIPPED INTERMITTENTLY INTO THE VALVE SEAT OF THE BALANCE CHAMBER VALVE VDABK1, PREVENTING THE VALVE FROM CLOSING PROPERLY AND THUS CAUSING THE DESCRIBED BALANCE DEVIATION THE SLIVER WAS IDENTIFIED TO BE OF THE SAME MATERIAL AS THE BALANCE CHAMBER HOUSING. ONLY A SLIVER OF THIS PARTICULAR SIZE AND SHAPE WAS ABLE TO SLIP INTO THE VALVE SEAT. A SMALLER SLIVER WOULD HAVE BEEN RINSED OUT AND A BIGGER SLIVER WOULD NOT HAVE BEEN ABLE TO ENTER THE VALVE SEAT. IF THE SLIVER WOULD HAVE BEEN IN THE VALVE SEAT DURING THE SELF-TEST OF THE DIALOG+ MACHINE KEEPING THE VALVE OPEN, THIS WOULD HAVE BEEN DETECTED BY THE DIALOG+ MACHINE AND ALARMED. A THERAPY START WOULD THEN NOT HAVE BEEN POSSIBLE. DURING THE PRODUCTION PROCESS, ALL BALANCE CHAMBER HOUSINGS ARE SUBJECTED FIRST TO A MANUAL PRE-DEBURING. THEREAFTER THEY ARE WASHED IN AN ULTRASONIC BATH, DRIED IN A COMPARTMENT DRYER AND AFTERWARDS WITH COMPRESSED AIR. THEN THEY ARE THERMALLY DEBURRED AND WASHED AGAIN AS DESCRIBED. THE TWO CLEANING PROCEDURES AS WELL AS THE DRYING PROCESS WITH COMPRESSED AIR REMOVE SPLINTERS WHICH MIGHT HAVE ARISEN DURING THE PRODUCTION PROCESS. AT THE END OF THE PRODUCTION PROCESS THE BALANCE CHAMBER HOUSINGS ARE SUBJECTED TO A 100% VISUAL CONTROL FOR THE ABSENCE OF BURRS AND SPLINTERS. THE SUBSEQUENT ASSEMBLY PROCESS OF THE BALANCE CHAMBERS WAS REVIEWED. THERE IS NO PROCESS WHERE SPLINTERS ARE GENERATED, ALL WORKING AND STORAGE AREAS ARE FREE OF SPLINTERS. THEREFORE, IT IS EXCLUDED THAT THE SPLINTER HAD ENTERED DURING THE ASSEMBLY PROCESS. SINCE THE IMPLEMENTATION OF THE PRODUCTION PROCESS DESCRIBED ABOVE, NO SIMILAR CASE IS KNOWN. BASED ON THE INVESTIGATION AND THE REVIEW OF THE MANUFACTURING PROCESSES, THE PROBABILITY OF OCCURRENCE OF THIS CASE IS ASSESSED AS BEING INCREDIBLE. THEREFORE, THIS CASE IS ASSESSED AS A SINGLE CASE AND NO FURTHER ACTIONS WILL BE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349945 DIALOG A +INCL. BIC HEMODIALYSIS SYSTEM FKJ B.BRAUN AVITUM AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other