BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMHEART

    MDR report key: 2843621 · Received October 22, 2012

    Report

    Report Number
    2843621
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 15, 2012
    Report Date
    October 22, 2012
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TANDEM HEART PLACED ON PATIENT. LESS THAN 2 WEEKS LATER, THE DEVICE STOPPED WORKING (PUMP AND CONTROLLER). PATIENT ABLE TO MAINTAIN FLOW. NO CIRCULATION OF THE TANDEM LED TO RETROGRADE FLOW. REPLACEMENT DEVICE ORDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEMHEART PVAD DSQ CARDIAC ASSIST, INC. EC-1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR CARDIAC DRUGS