BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIO QUIP MCH-1000(I)

    MDR report key: 11776792 · Received May 4, 2021

    Report

    Report Number
    MW5101171
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    October 14, 2020
    Report Date
    May 3, 2021
    Manufacturer
    CARDIOQUIP LLC
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HEATER COOLER CULTURED ON (B)(6) 2020 AS PART OF CULTURING PROGRAM. RESULTS POSITIVE. TESTED AGAIN ON (B)(6) 2021, POSITIVE AGAIN. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670841 CARDIO QUIP MCH-1000(I) CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC CARDIOQUIP LLC 12161072

    Patients

    Seq Age Sex Outcome Treatment
    1