BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALOG A + HE/BIC

    MDR report key: 5851934 · Received August 5, 2016

    Report

    Report Number
    3002879653-2016-00027
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Date of Event
    July 30, 2016
    Report Date
    August 2, 2016
    Manufacturer
    B. BRAUN AVITUM AG - MELSUNGEN
    Product Code
    FKJ
    PMA / PMN Number
    K083460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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). ADDITIONAL INFORMATION ALONG WITH THE TREND ANALYSIS HAS BEEN REQUESTED FROM THE FACILITY AND 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). CUSTOMER REPORTED THAT THE SCREEN OF THE DIALOG+ DIALYSIS MACHINE (SN (B)(6)) FROZE ABOUT 3.5 HOURS INTO THERAPY, 30 MINUTES BEFORE THE THERAPY WAS SCHEDULED TO BE TERMINATED. IT WAS DESCRIBED THAT NEITHER THE TOUCH SCREEN NOR THE HARD KEYS FOR THE BLOOD PUMP OPERATED. THE USER REBOOTED THE DIALYSIS MACHINE, BUT THE SITUATION WAS NOT REMEDIED. IN ADDITION, IT WAS REPORTED THAT THE BLOOD PUMP STOOD STILL. FROM THE INFORMATION THAT WAS PROVIDED, IT IS CONCLUDED THAT THE CONTROL ELEMENTS FROZE AND THAT THE BLOOD PUMP STOPPED BECAUSE THE DIALYSIS MACHINE WAS REBOOTED BY THE OPERATOR. AFTER REBOOTING THE DIALOG+ MACHINE, THE BLOOD PUMP HAS TO BE STARTED MANUALLY, WHICH WAS NOT POSSIBLE SINCE THE RESPECTIVE KEYS DID NOT RESPOND. THE CUSTOMER REPORT ALSO INDICATED THAT DUE TO THE LONG WAIT, THE BLOOD COAGULATED IN THE EXTRACORPOREAL CIRCUIT AND COULD NOT BE RETURNED MANUALLY WITH THE CRANK. THE PATIENT DID NOT SUFFER FROM ANY SYMPTOMS DUE TO THE LOSS OF THE BLOOD IN THE EXTRACORPOREAL CIRCUIT AND MEDICAL INTERVENTION WAS NOT NECESSARY. ACCORDING TO THE SAME REPORT THE DIALOG+ DIALYSIS MACHINE IS IN USE AGAIN WITHOUT ANY ISSUES. ALL INFORMATION ASSOCIATED WITH THIS EVENT WAS FORWARDED TO THE EQUIPMENT MANUFACTURER B. BRAUN AVITUM - GERMANY. NEITHER A COMPONENT, NOR THE DATA RECORD OF THE THERAPY WERE SUBMITTED BY THE FACILITY FOR INVESTIGATION. WITHOUT HAVING THE POSSIBILITY TO INVESTIGATE THE DATA RECORD OF THE DIALOG+ MACHINE, THE MANUFACTURER COULD NOT DETERMINE THE EXACT CAUSE FOR THE UNRESPONSIVE TOUCH SCREEN AND FUNCTIONLESS PUMP CONTROL BUTTONS. THE MONITOR OF THE DIALOG+ MACHINE IS TESTED DURING THE PREPARATION PHASE. A DEFECTIVE MONITOR TRIGGERS A WARNING. EVEN WITH AN INOPERATIVE MONITOR, A TREATMENT CAN BE TERMINATED SINCE THE ALARM AND CONTROL SYSTEM OPERATES INDEPENDENT FROM THE SCREEN. THEREFORE, ALL MONITORING FUNCTIONS AND THE SIGNAL LAMPS ON THE MONITOR REMAIN ACTIVE. THE BLOOD PUMP IS CHECKED DURING THE SELF-TEST OF THE DIALOG+ DIALYSIS MACHINE IN THE PREPARATION PHASE. IF THE BLOOD PUMP DOES NOT OPERATE, THE SELF-TEST IS NOT PASSED AND A THERAPY START IS NOT POSSIBLE. DURING THERAPY, THE BLOOD-PUMP IS PERMANENTLY MONITORED BY THE SUPERVISOR. IF THE BLOOD PUMP DOES NOT ROTATE, THE SUPERVISOR DETECTS THIS, AN ALARM IS TRIGGERED AND THE MACHINE SWITCHES IN PATIENT-SAFE MODE. SINCE THE CUSTOMER INDICATED THAT THERE WAS NO ALARM, IT IS CONCLUDED THAT THE BLOOD PUMP IN THE CURRENT CASE STOPPED ONLY AFTER THE DIALYSIS MACHINE HAD BEEN REBOOTED AS OUTLINED ABOVE. IF THE BLOOD PUMP BECOMES INOPERATIVE DURING THERAPY, THE CUSTOMER HAS THE OPTION TO RETURN THE BLOOD IN THE EXTRACORPOREAL CIRCUIT USING THE CRANK. THE RESPECTIVE PROCEDURE IS DESCRIBED IN THE OPERATING MANUAL OF THE DIALOG+ MACHINE. ACCORDING TO THE CUSTOMER'S REPORT THE LONG WAIT CAUSED THE BLOOD TO COAGULATE, WHICH PREVENTED THE USER TO RETURN THE BLOOD MANUALLY TO THE PATIENT. ALL INFORMATION CONCERNING THIS INCIDENT HAS BEEN INCLUDED IN OUR TREND ANALYSIS OF THE PRODUCT LINE. A HISTORICAL REVIEW OF THE CUSTOMER COMPLAINT DATABASE, REVEALED NO ADVERSE TRENDS REGARDING THIS ISSUE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: PRODUCT: 710200L, SERIAL (B)(6), PROBLEM: STAFF REPORTED THAT THIS MACHINE "FROZE UP ON US". OCCURRED (B)(6) 2016. NO ALARM TRIGGERED. FACILITY CONFIRMED THAT THE PATIENT FELT FINE AND HIS BLOOD PRESSURE WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502741 DIALOG A + HE/BIC HAEMODIALYSIS SYSTEM FKJ B. BRAUN AVITUM AG - MELSUNGEN

    Patients

    Seq Age Sex Outcome Treatment
    1