BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR COOLER-HEATER (MCH)

    MDR report key: 10940079 · Received December 3, 2020

    Report

    Report Number
    10940079
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    November 25, 2020
    Report Date
    November 30, 2020
    Manufacturer
    CARDIOQUIP
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2020, OUR FACILITY WAS NOTIFIED BY THE FDA THAT PATIENTS FROM ONE ORGANIZATION HAD EXPERIENCED NTM INFECTIONS (M ABSCESSUS) AFTER HEART SURGERY WHERE THE CARDIOQUIP HEATER COOLER DEVICES WERE USED. THIS PROMPTED OUR ORGANIZATION TO SEND SAMPLES FROM OUR MACHINES TO AN OUTSIDE LAB FOR TESTING. 5/8 CARDIOQUIP DEVICES CAME BACK POSITIVE FOR NTM. LAB RESULTS AVAILABLE. WE HAVE NOT IDENTIFIED ANY RELATED INFECTIONS AT THIS TIME. UPON RECEIVING THESE RESULTS, A GROUP CONVENED AND LEARNED THE FOLLOWING: TESTING OF OUR 8 DEVICES REVEALED 5 OF 8 MACHINES CONTAMINATED WITH NTM, NO KNOWN INFECTIONS WITH ECMO PATIENTS AND USE OF CARDIOQUIP IN THE LITERATURE, RISK FOR INFECTION IS VERY LOW, BUT NOT ZERO. WE ONLY USE THE DEVICE TO HEAT-NOT TO COOL. STANDARD WORK FOR MACHINE USE AND CLEANING VERY RIGOROUS, HOWEVER DESIGN OF MACHINE IS FLAWED. NEXT STEPS INCLUDE: CONTINUED USE OF THE THREE MACHINES THAT TESTED NEGATIVE, SINCE THERE IS NO ACCEPTABLE SUBSTITUTE. ALL THREE WILL BE RE-TESTED, REPORT TO FDA, CONNECT WITH THE MANUFACTURER, POTENTIAL RETROSPECTIVE REVIEW OF 200 ECMO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402998 MODULAR COOLER-HEATER (MCH) CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC CARDIOQUIP MCH-1000 537766

    Patients

    Seq Age Sex Outcome Treatment
    1