BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 15366440 · Received September 6, 2022

    Report

    Report Number
    3007899424-2022-00104
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Date of Event
    January 26, 2022
    Report Date
    August 7, 2023
    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. CARDIOQUIP REQUESTED PATIENT INFORMATION BUT PATIENT INFORMATION WAS NOT PROVIDED. NO DETERMINATION WAS ABLE TO BE MADE ABOUT WHETHER THE DEVICE CAUSED AN ADVERSE EVENT AS CARDIOQUIP DOES NOT HAVE ACCESS TO THE DEVICE TO INVESTIGATE AND NO PATIENT INFORMATION WAS GIVEN.

    Additional Manufacturer Narrative · 0

    CARDIOQUIP RECEIVED THE DEVICE AND PERFORMED AN HPC TEST TO GAIN A QUANTITATIVE ANALYSIS OF THE WATER QUALITY. THE RESULTS CAME BACK OUTSIDE OF CARDIOQUIP'S SPECIFICATIONS FOR BACTERIAL CONTAMINATION. AN INTERNAL WATER PATHWAY REPLACEMENT WAS PERFORMED ON THE DEVICE TO RETURN IT TO SPECIFICATION. FOLLOWING THE REPAIR, THE DEVICE PASSED INSPECTION AND IS FULLY FUNCTIONAL.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ALL DEVICES AT THIS FACILITY HAVE TESTED POSITIVE FOR NTM.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ALL OF THEIR DEVICES HAVE TESTED POSITIVE FOR NTM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2182592 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown