BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOQUIP MCH-1000

    MDR report key: 9396839 · Received November 29, 2019

    Report

    Report Number
    MW5091375
    Event Type
    Injury
    Date Received
    November 29, 2019
    Date of Event
    November 1, 2019
    Report Date
    November 28, 2019
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MULTIPLE CARDIAC SURGERY AND ECMO HOSPS IN (B)(6) AND (B)(6) EXPERIENCING SERIOUS PRODUCT ISSUES WITH HEATER /COOLING UNITS RELIABILITY AND QUALITY MANUFACTURED BY CARDIOQUIP LLC. I TRAVEL TO MANY HOSPS IN THESE STATES AND HAVE HEARD AND SEEN THE CARDIOQUIP LLC MCH-1000 DEVICE PULLED FROM TREATMENT ROOMS DUE TO DEVICES INABILITY TO REWARM PTS ON CARDIOPULMONARY BYPASS. MOST HOSPS REPORTING THE SAME ISSUES WITH THE MCH-1000 DEVICES. THE INABILITY FOR THE DEVICE TO PROPERLY PERFORM MAY LEAD TO EXTENDED TIMES PTS NEED TO REMAIN ON CPB TO BE RETURNED TO NORMAL BODY TEMPERATURE. I REVIEWED THE MAUDE DATABASE AND ONLY FOUND FOUR OLD CARDIOQUIP COMPLAINTS. AS I UNDERSTAND, A MFR IS REQUIRED UNDER FDA REGULATION TO SELF REPORT COMPLAINTS RECEIVED FROM HOSP ON DEVICES FAILURE / COMPLIANCE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186535 CARDIOQUIP MCH-1000 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC CARDIOQUIP, LLC MCH-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention