BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 15366434 · Received September 6, 2022

    Report

    Report Number
    3007899424-2022-00112
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Date of Event
    March 8, 2022
    Report Date
    September 6, 2022
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS REPORTING THE FOLLOWING COMPLAINT AFTER A 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. WATER SAMPLES FROM THE DEVICE MEASURED GREATER THAN 100 MPN/ML. THUS, IT WAS RECOMMENDED TO THE USER THAT THE DEVICE UNDERGO AN INTERNAL WATER PATH REPLACEMENT. THE DEVICE UNDERWENT AN INTERNAL WATER PATH REPLACEMENT AND AFTERWARDS, ACCORDING TO LAB RESULTS, THE CFU COUNT WAS WITHIN ACCEPTABLE LIMITS PER WI-09.

    Description of Event or Problem · 0

    CUSTOMER REPORTS WATER SAMPLE CAME BACK FORM TESTING AS >73800 MPN/ML FOR WHICH THEY RECOMMEND AN INTERNAL WATER PATHWAY REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2182586 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown