BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER-HEATER (MCH)

    MDR report key: 11863523 · Received May 21, 2021

    Report

    Report Number
    11863523
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    January 7, 2021
    Report Date
    April 19, 2021
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT BECAME BRADYCARDIC/HYPERTENSIVE SUDDENLY AROUND 1430, IT WAS FOUND THAT THE WATER HEATER ON THE ECMO CIRCUIT HAD BEEN PUT ONTO STANDBY UNKNOWINGLY, UPON DISCOVERING THIS IT WAS RESTARTED, PATIENT WAS REWARMED SLOWLY AND BRADYCARDIA/ HYPERTENSION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760622 CARDIOQUIP MODULAR COOLER-HEATER (MCH) CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 30 DA