BEUDAMED
    FDA Adverse Event Death Summary report: N

    10MM HEMASHIELD ARTERIAL CANNULA

    MDR report key: 789615 · Received November 30, 2006

    Report

    Report Number
    1220648-2006-00003
    Event Type
    Death
    Date Received
    November 30, 2006
    Date of Event
    October 20, 2006
    Report Date
    November 25, 2006
    Manufacturer
    ABIOMED, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P900023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A CONVERSATION WITH THE PHYSICIAN, THE LEAKING CANNULA LED TO HEMORRHAGE, WHICH ULTIMATELY CAUSED PT DEATH. THE USER FACILITY HAS SENT THE DEVICE, BUT THE MFR HAS NOT RECEIVED IT AS OF 11/25/2006.

    Description of Event or Problem · 1

    PHYSICIAN IMPLANTED AN LVAD IN PT AND OBSERVED EXCESSIVE BLEEDING FROM ALL OVER THE GRAFT. PHYSICIAN TRIED TO CONTROL THE BLEEDING, BUT WAS UNABLE TO. PT EXPIRED FROM HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10MM HEMASHIELD ARTERIAL CANNULA CARDIAC ASSIST DSQ ABIOMED, INC. * 06EPS0920

    Patients

    Seq Age Sex Outcome Treatment
    1 Death