BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR HEATER COOLER

    MDR report key: 12740168 · Received November 2, 2021

    Report

    Report Number
    3007899424-2021-00033
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    August 19, 2021
    Report Date
    October 12, 2022
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 NOTIFIED CARDIOQUIP, THAT A PATIENT WAS INVOLVED DURING THE MALFUNCTION ALTHOUGH NO PATIENT INFORMATION WAS COMMUNICATED. CARDIOQUIP'S INVESTIGATION DETERMINED THAT THE DEVICE IS FULLY OPERATIONAL.

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS NOT BEEN RECEIVED BY CARDIOQUIP. ONCE THE DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION HAS BEEN COMPLETED, CARDIOQUIP WILL FILE SUPPLEMENTARY REPORTS.

    Description of Event or Problem · 0

    CUSTOMER REPORTS THAT THEIR DEVICE IS OVERHEATING WHILE ON PATIENTS AFTER ADDING ICE AND CHANGING WATER IN THE TANK PERIODICALLY.

    Description of Event or Problem · 0

    CUSTOMER REPORTS THAT THEIR DEVICE IS OVERHEATING WHILE ON PATIENTS AFTER ADDING ICE AND CHANGING WATER IN THE TANK PERIODICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639741 CARDIOQUIP MODULAR HEATER COOLER CARDIOPULMONARY BYPASS COOLER HEATER DWC CARDIOQUIP, LLC MCH-1000(M)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown