BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 17221160 · Received June 28, 2023

    Report

    Report Number
    3007899424-2023-00211
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    August 16, 2022
    Report Date
    June 28, 2023
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A CARDIOQUIP CUSTOMER NOTIFIED CARDIOQUIP THAT THE CPG OF THEIR DEVICE WAS NOT COOLING. UPON INSPECTION OF THE DEVICE, A CARDIOQUIP TECHNICIAN IDENTIFIED THAT THE CPG VALVES WERE NONFUNCTIONAL AND REQUIRED REPLACEMENT. FOLLOWING THE REPAIR, THE DEVICE PASSED INSPECTION AND IS FULLY FUNCTIONAL.

    Description of Event or Problem · 0

    CUSTOMER NOTIFIED US "WHEN I WENT TO TEST THE TEMPERATURE CONTROLS THIS MORNING (MAIN VS. CPG), I FOUND OUT THAT THE CPG SIDE IS NOT ABLE TO INDEPENDENTLY REGULATE TEMPERATURE. FOR INSTANCE...WE OFTEN RUN COLD CARDIOPLEGIA AND KEEP OUR PATIENTS WARM. THIS UNIT IS NOT ABLE TO INDEPENDENTLY RUN COLD TEMPERATURE ON THE CARDIOPLEGIA SIDE AND WARM TEMPERATURE ON THE PATIENT SIDE (YES, THERE IS A SUFFICIENT ICE BLOCK). IT APPEARS THAT THE TEMPERATURE OF THE CPG SIDE IS ONLY ABLE TO MIMIC THE TEMPERATURE OF THE MAIN. THERE WAS NEVER AN ISSUE WITH THE TEMPERATURE CONTROL WHEN THE UNIT WAS SENT OUT FOR REPAIR." THIS ISSUE WAS IDENTIFIED ON 08/16/2022, NO PATIENT INVOLVEMENT WAS REPORTED. (NQA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158661 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown