BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 6033547 · Received October 17, 2016

    Report

    Report Number
    6033547
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 20, 2016
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    DTQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ON ECMO MACHINE FOR SEVERAL DAYS. THE ECMO (CARDIOHELP) CIRCUIT SCREEN WENT BLACK, PATIENT'S SATURATION DROPPED TO 20%, SYSTOLIC BLOOD PRESSURE (SBP) TO 30, AND HEART RATE TO 25 BPM. THE PATIENT WAS BAGGED AND PRESSORS STARTED. EPINEPHRINE GIVEN WHILE THE ECMO SPECIALIST STARTED TO HANDCRANK THE ECMO CIRCUIT. ATTEMPTS TO TURN ON THE CARDIOHELP FAILED. MACHINE/CIRCUIT SWITCHED OUT. THE PATIENT CODED DURING THIS TIME AND SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685412 CARDIOHELP CONSOLE, HEART-LUNG MACHINE DTQ MAQUET CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR