BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 15366446 · Received September 6, 2022

    Report

    Report Number
    3007899424-2022-00103
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Date of Event
    January 26, 2022
    Report Date
    January 23, 2024
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. THE CUSTOMER REPORTS THAT DEVICES AT THE FACILITY HAVE TESTED POSITIVE FOR NTM. THE DEVICE HAS NOT BEEN RECEIVED BY CARDIOQUIP AND THEREFORE A FULL INVESTIGATION OF THE SUSPECTED DEVICE AND SUBSEQUENT REPAIR AND INSPECTION HAS NOT BEEN ABLE TO BE PERFORMED.

    Additional Manufacturer Narrative · 0

    FOLLOWING TEST RESULTS OUTSIDE OF CARDIOQUIP SPECIFICATIONS, CARDIOQUIP RECOMMENDED THAT THE DEVICE RECEIVE AN INTERNAL WATER PATHWAY REPLACEMENT. THE CUSTOMER THEN SENT THE DEVICE TO CARDIOQUIP FOR REPAIR. THE DEVICE WAS RETURNED TO SPECIFICATION VIA AN INTERNAL WATER PATHWAY REPLACEMENT. FOLLOWING THE REPAIR, THE DEVICE PASSED INSPECTION AND IS FULLY FUNCTIONAL.

    Description of Event or Problem · 0

    CUSTOMER REPORTS ALL DEVICES AT THE FACILITY TESTED POSITIVE FOR NTM.

    Description of Event or Problem · 0

    CUSTOMER REPORTS ALL DEVICES AT THE FACILITY TESTED POSITIVE FOR NTM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2182598 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown