BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE HVAD

    MDR report key: 3150810 · Received June 6, 2013

    Report

    Report Number
    3150810
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 18, 2013
    Report Date
    June 3, 2013
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED W/ HEMATURIA, HIGH POWER ALARMS, SOB AND MALAISE, PT WAS STARTED ON HEPARIN, MILRINONE AND INTEGRELIN. PLASMA HEMOGLOBIN, LDH AND POWERS CONTINUED TO RISE OVER NIGHT. PUMP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250345 HEARTWARE HVAD LVAD DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1