BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG 2ND GEN

    MDR report key: 16411735 · Received February 17, 2023

    Report

    Report Number
    MW5115078
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    January 8, 2023
    Report Date
    February 16, 2023
    Manufacturer
    THORATEC CORP.
    Product Code
    DWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    M1 NO FLOW ALARM ON ECMO MACHINE, CONSOLE SCREEN FLICKERING, MONITORING SCREEN BLACK, NO FLOW OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611853 CENTRIMAG 2ND GEN CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA THORATEC CORP. 201-30300

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention