BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 14847584 · Received June 28, 2022

    Report

    Report Number
    3007899424-2022-00035
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    December 9, 2021
    Report Date
    May 31, 2022
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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. CUSTOMER REPORTS GREEN DISCOLORATION IN DEVICE TUBING BUT COULD NOT MAKE THEIR DEVICE AVAILABLE FOR A WATER PATH REPLACEMENT AND INVESTIGATION. THEREFORE, A DETERMINATION COULD NOT BE MADE REGARDING THE CAUSE OF THE GREEN DISCOLORATION.

    Description of Event or Problem · 0

    CUSTOMER REPORTS GREEN DISCOLORATION OF TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910460 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000 (I)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown