BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 15606571 · Received October 14, 2022

    Report

    Report Number
    3007899424-2022-00146
    Event Type
    Malfunction
    Date Received
    October 14, 2022
    Date of Event
    December 16, 2019
    Report Date
    October 13, 2022
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS REPORTING THE FOLLOWING COMPLAINT AFTER VOLUNTARY REVIEW OF ALL COMPLAINTS (REPORTABLE OR NOT) SINCE 2016. THIS REPORT IS BEING FILED NOW, AFTER BEING SCRUTINIZED UNDER A NEWLY REVISED RISK MATRIX, RECENTLY ADOPTED AFTER INSPECTION. CARDIOQUIP WAS MADE AWARE OF A REPORT SUBMITTED THROUGH FDA'S MEDWATCH PROGRAM. THE REPORT DOES NOT IDENTIFY THE DEVICE(S) INVOLVED OR OTHER ESSENTIAL INFORMATION REQUIRED FOR CARDIOQUIP TO INVESTIGATE THE REPORTED EVENT. CARDIOQUIP IS REPORTING THIS EVENT TO RESPOND TO THE MEDWATCH REPORT SUBMITTED PREVIOUSLY.

    Description of Event or Problem · 0

    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 TIME PTS NEED TO REMIAN ON CPB TO BE RETURNED TO NORMAL BODY TEMPERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2566812 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown