BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM LIFE

    MDR report key: 11444559 · Received March 8, 2021

    Report

    Report Number
    MW5099853
    Event Type
    Injury
    Date Received
    March 8, 2021
    Date of Event
    March 3, 2021
    Report Date
    March 4, 2021
    Manufacturer
    LIVANOVA / CARDIAC ASSIST, INC. DBA TANDEM LIFE
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SUPPLIER SUPPLIED A WRONG KIT. THE PUMP WAS INCOMPATIBLE WITH THE CONSOLE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338144 TANDEM LIFE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM LIVANOVA / CARDIAC ASSIST, INC. DBA TANDEM LIFE 5740-2417

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention