BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALOG®

    MDR report key: 15078165 · Received July 21, 2022

    Report

    Report Number
    2521402-2022-00037
    Event Type
    Death
    Date Received
    July 21, 2022
    Date of Event
    June 22, 2022
    Report Date
    July 18, 2022
    Manufacturer
    B. BRAUN AVITUM AG
    Product Code
    KDI
    UDI-DI
    04046963686345
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT NUMBER (B)(4). THE TECHNICAL INSPECTION OF THE DIALOG+ MACHINE DID NOT SHOW ANY MALFUNCTION. IT OPERATED AS INTENDED. THE EVALUATION OF THE DATA RECORD OF THE DIALOG+ MACHINE SHOWED A SUCCESSFULLY PASSED PREPARATION PHASE. IN THE FIRST 37 MINUTES OF THE THERAPY NUMEROUS ARTERIAL PRESSURE ALARMS (ARTERIAL PRESSURE - LOWER LIMIT OR ARTERIAL PRESSURE - LOWER LIMIT (SUP)) WERE TRIGGERED OFTEN FOLLOWED BY VENOUS PRESSURE ALARMS (VENOUS PRESSURE LOWER LIMIT (SUP)) DUE TO THE BLOOD PUMP STOP BECAUSE OF THE ALARM. FOLLOWING THESE ALARMS, THE DIALOG+ MACHINE SWITCHED INTO PATIENT-SAFE MODE (BLOOD PUMP STOP, VENOUS TUBE CLAMP SAKV CLOSED). FROM THE TREND DATA, THE CAUSE FOR THESE ALARMS IS NOT COMPREHENSIBLE. THE ALARMS WERE ALL ACKNOWLEDGED IN A TIMELY MANNER BY THE OPERATOR. ABOUT 37 MINUTES INTO THERAPY AN AIR ALARM WAS TRIGGERED (SAD-AIR! AND S.A.D. (SUP)). FOLLOWING THIS ALARM, THE DIALOG+ MACHINE SWITCHED INTO PATIENT-SAFE MODE. THE ALARM WAS ACKNOWLEDGED BY THE USER AND THE THERAPY WAS CONTINUED. SIX MINUTES LATER, THE ALARM ABPM: SYS PRESS. IS TOO LOW WAS TRIGGERED BECAUSE THE BLOOD PRESSURE MEASURED BY THE RESPECTIVE MODULE OF THE DIALOG+ MACHINE WAS 97/64 MMHG, PULSE RATE 94 BPM AND THUS BELOW THE SET LIMIT. TEN SECONDS LATER MINIMAL UF WAS ACTIVATED BY THE OPERATOR AND SHORTLY THEREAFTER, NO MORE RED WAS DETECTED AT THE RED DETECTOR OF THE SAD, INDICATING THAT THE BLOOD IN THE EXTRACORPOREAL CIRCUIT HAD BEEN RETURNED TO THE PATIENT. THIS WAS OBVIOUSLY THE TIME WHEN THE THERAPY WAS STOPPED BECAUSE THE PATIENT HAD DEVELOPED THE DESCRIBED SYMPTOMS AND WAS DISCONNECTED FROM THE DIALYSIS MACHINE. THE EVALUATION OF THE TREND DATA SHOW NO INDICATION OF A MALFUNCTION. THE TECHNICAL INSPECTION OF THE DIALOG+ ON-SITE AS WELL AS THE EVALUATION OF THE DATA RECORD SHOW THAT THE DIALYSIS MACHINE OPERATED AS INTENDED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A PATIENT CODED DURING A TREATMENT WITH A DIALOG+ DIALYSIS MACHINE AND PASSED AWAY. AS PER FACILITY POLICY THE CUSTOMER REQUESTED AN EVALUATION OF THE DIALYSIS MACHINE BY THE MANUFACTURER. THE CUSTOMER DESCRIBED THE INCIDENT IN MORE DETAIL AS FOLLOWS. ABOUT 46 MINUTES INTO THERAPY, THE PATIENT DEVELOPED SHORTNESS OF BREATH. OXYGEN (2L/NC) AND SALINE WAS ADMINISTERED AND THE DIALYSIS TREATMENT WAS DISCONTINUED. SINCE THE SYMPTOMS DID NOT RESOLVE, OXYGEN WAS INCREASED FROM 2 TO 10L VIA MASK AND THE RAPID RESPONSE TEAM WAS CALLED. THE PATIENT BECAME UNRESPONSIVE AND CONTINUED TO DETERIORATE. THE MD WHO WAS CALLED PRONOUNCED THE PATIENT HEAD. THE PATIENT HAD A DNR ORDER. THE CUSTOMER STATED THAT THERE WAS NO INDICATION OF A MALFUNCTION OF THE DIALOG+ MACHINE. THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262170 DIALOG® HIGH PERMEABILIT KDI B. BRAUN AVITUM AG 710200L 04046963686345

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death