BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM HEART PUMP

    MDR report key: 8565032 · Received April 29, 2019

    Report

    Report Number
    MW5086256
    Event Type
    Malfunction
    Date Received
    April 29, 2019
    Date of Event
    April 10, 2019
    Report Date
    April 25, 2019
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH TANDEM RVAD AND HEARTWARE LVAD IN CTICU WENT FOR WALK WITH PT TODAY. DROPS OF BLOOD WERE NOTED COMING FROM TANDEM PUMP. PT RETURNED TO ROOM. UPON INSPECTION, PUMP HEAD WAS INTACT AND THE BLOOD WAS COMING FROM PUMP OUTFLOW AND TUBING CONNECTION. TUBING WAS SLID FURTHER ONTO PUMP HEAD AND ZIP TIED IN PLACE. ZIP TIE WAS ALSO ADDED TO PUMP INFLOW TUBING. NO FURTHER BLOOD NOTED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356457 TANDEM HEART PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM CARDIAC ASSIST, INC. 5120-0000

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other