BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALOG+ HDF-ONLINE INCL. AKKU/ABPM

    MDR report key: 5957172 · Received September 16, 2016

    Report

    Report Number
    3002879653-2016-00028
    Event Type
    Malfunction
    Date Received
    September 16, 2016
    Date of Event
    April 8, 2016
    Report Date
    August 19, 2016
    Manufacturer
    B. BRAUN AVITUM AG - MELSUNGEN
    Product Code
    FKJ
    PMA / PMN Number
    K083460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    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). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION BECOME AVAILABLE.

    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). B. BRAUN AVITUM AG BECAME AWARE OF A SOFTWARE ERROR IN SOFTWARE (SW) 8.2A OF THE DIALOG+ DIALYSIS MACHINE AFFECTING THE TIMER/STOP WATCH FUNCTION. THIS TIMER FUNCTION ONLY SERVES AS A SUPPORT TO THE USER TO REMIND OF AN ACTION THAT HAS TO BE TAKEN BY THE USER. THE FAILURE OCCURS ONLY IN SW 8.2A AND ONLY IN COMBINATION WITH OPTION ADIMEA. IN CERTAIN CONDITIONS AND ON RARE OCCASIONS, THE WARNING TRIGGERED TO REMIND THE USER IS RESET BY THE MACHINE WITHOUT USER INTERACTION. THE USER MIGHT NOT BE AWARE THAT THE REMINDER WAS TRIGGERED AT ALL. THE ROOT CAUSE OF THIS FAILURE IS A SINGLE ERROR IN SW 8.2A. IF THE ERROR OCCURS, THE WARNING SOUNDS AND THE YELLOW LIGHT FLASHES AS INTENDED, BUT THE WARNING IS RESET BY THE MACHINE WITHOUT USER INTERACTION. IF THE TIMER/STOP WATCH FUNCTION IS USED TO REMIND THE USER OF THE APPLICATION OR CHANGE OF A MEDICATION DURING THERAPY, AND THE REMINDER FAILS, THE PATIENT MIGHT SUFFER FROM CONSEQUENCES DEPENDENT ON THE MEDICATION INTENDED TO BE APPLIED. SINCE THE MARKET INTRODUCTION OF THE SW 8.2A IN 2010 ONLY ONE SINGLE CASE WAS REPORTED RECENTLY IN GERMANY DESCRIBING THIS SITUATION. IN THIS CASE THE CONCENTRATE WAS NOT CHANGED. THE PATIENT DID NOT SUFFER FROM ANY LONG-TERM CONSEQUENCES. THE FAILURE HAS BEEN CORRECTED WITH SOFTWARE VERSION 8.2B. ALL DIALOG+ DIALYSIS MACHINES WITH SOFTWARE 8.2A AND OPTION ADIMEA MUST BE UPDATED TO SOFTWARE 8.2B. BASED ON THE INVESTIGATION RESULTS OF THIS COMPLAINT A VOLUNTARY RECALL HAD BEEN INITIATED IN THE COUNTRIES WHERE THE SOFTWARE VERSION 8.2A OF THE DIALOG+ MACHINE IN COMBINATION WITH OPTION ADIMEA IS MARKETED. SINCE THE AFFECTED SOFTWARE VERSION 8.2A IS NOT MARKETED IN THE USA, IT IS NOT REQUIRED TO INCLUDE THE USA IN THIS VOLUNTARY RECALL.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN GERMANY): A USER IN GERMANY REPORTED THAT DURING A THERAPY WITH A DIALOG+ DIALYSIS MACHINE, THE TO-DO-LIST FUNCTION WAS USED TO REMIND THE USER TO CHANGE THE DIALYSIS CONCENTRATE DURING THERAPY. THE WARNING TO REMIND THE USER TO CHANGE THE CONCENTRATE OCCURRED BUT RESET AUTOMATICALLY BY THE DEVICE. CONSEQUENTLY, THE NURSE WAS NOT REMINDED BY THE DEVICE AND THE CONCENTRATE WAS NOT CHANGED. THE DIALYSIS THERAPY WAS FINISHED AS SCHEDULED. THE FOLLOWING THERAPY WAS PLANNED FOR 2016-04-11 IN THE EVENING BUT HAD TO TAKE PLACE IN THE MORNING OF (B)(6) 2016 BECAUSE THE PATIENT HAD DEVELOPED A HYPERKALEMIA AND COMPLAINED ABOUT PAIN THROUGHOUT THE BODY. THE COMPLAINED SW VERSION IS NOT MARKETED IN THE USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606965 DIALOG+ HDF-ONLINE INCL. AKKU/ABPM HEMODIALYSIS SYSTEM FKJ B. BRAUN AVITUM AG - MELSUNGEN

    Patients

    Seq Age Sex Outcome Treatment
    1