BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALOG+

    MDR report key: 10137246 · Received June 10, 2020

    Report

    Report Number
    3002879653-2020-00004
    Event Type
    Death
    Date Received
    June 10, 2020
    Date of Event
    May 30, 2020
    Report Date
    July 17, 2020
    Manufacturer
    B. BRAUN AVITUM AG - MELSUNGEN
    Product Code
    KDI
    UDI-DI
    04046963686345
    PMA / PMN Number
    K083460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). A B. BRAUN TECHNICIAN COMPLETED A TECHNICAL SAFETY CHECK ON THE MACHINE PER THE SERVICE MANUAL CHECKLIST. A SELF-TEST WAS RUN AND A MOCK THERAPY WAS PERFORMED, BOTH WITH PASSING RESULTS. THE MACHINE WAS DISINFECTED AND RELEASED FOR USE. THE EVALUATION OF THE DATA RECORD OF THE DIALOG+ MACHINE SHOWS THAT THE THERAPY RAN FOR 1 HR 14 MINUTES WITHOUT ANY ISSUE. THEN, THE ALARMS "ABPM: SYS PRESS. IS TOO LOW" AND "ABPM: DIA PRESS. IS TOO LOW" WERE TRIGGERED BECAUSE THE PATIENT'S BLOOD PRESSURE HAD DROPPED TO 49:11 MMHG (PULSE 80 BPM). THE OPERATOR ACKNOWLEDGED THE ALARMS AND ACTIVATED MINIMAL ULTRAFILTRATION. THIS WAS OBVIOUSLY THE TIME WHEN THE PATIENT DEVELOPED THE SHORTNESS OF BREATH. SEVEN MINUTES LATER THE BLOOD PRESSURE WAS 133:49 MMHG (PULSE 80 BPM). THE OPERATOR DEACTIVATED THE MINIMAL ULTRAFILTRATION AND ACTIVATED IT AGAIN SHORTLY THEREAFTER. THE ALARM "ABPM: DIA PRESS. IS TOO LOW" WAS TRIGGERED AGAIN BECAUSE THE PATIENT'S BLOOD PRESSURE WAS 174:29 MMHG (PULSE 93 BPM). FINALLY, THE BLOOD WAS RETURNED TO THE PATIENT 1 HR 30 MINUTES AFTER THERAPY START. THE EVALUATION OF THE DATA RECORD OF THE DIALOG+ MACHINE DOES NOT SHOW A MALFUNCTION. THE DIALYSIS MACHINE OPERATED AS INTENDED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A B. BRAUN TECHNICIAN COMPLETED A TECHNICAL SAFETY CHECK ON THE MACHINE PER THE SERVICE MANUAL CHECKLIST. A SELF-TEST WAS RUN AND A MOCK THERAPY WAS PERFORMED, BOTH WITH PASSING RESULTS. THE MACHINE WAS DISINFECTED AND RELEASED FOR USE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: PATIENT COMPLAINED OF SHORTNESS OF BREATH (SOB) DURING TREATMENT AND WAS TAKEN OFF TREATMENT EARLY. PATIENT'S OXYGEN SATURATION LEVEL DROPPED BELOW 88%. ONCE THE BLOOD WAS RETURNED THE PATIENT CODED AND PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601224 DIALOG+ DIALYZER, HIGH PERMEABILIT KDI B. BRAUN AVITUM AG - MELSUNGEN 710200L 04046963686345

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other