BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE LVAS

    MDR report key: 10017341 · Received May 1, 2020

    Report

    Report Number
    10017341
    Event Type
    Injury
    Date Received
    May 1, 2020
    Date of Event
    December 26, 2019
    Report Date
    April 28, 2020
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEARTWARE LEFT VENTRICULAR ASSIST DEVICE (LVAD) PATIENT PRESENTED WITH HIGH WATT ALARMS, ABNORMAL LVAD FUNCTION/WAVEFORMS AND HEMOGLOBINURIA IN THE SETTING OF INTERNATIONAL NORMALIZED RATIO (INR) 1.7 AND ASPIRIN 325MG; REQUIRING HEARTWARE TO HEARTWARE EXCHANGE A WEEK LATER. PATIENT WAS THEN FOUND TO HAVE LEFT MIDDLE CEREBRAL ARTERY TERRITORY INFARCT ON POINT OF DISCHARGE #1. INTRAOPERATIVE FINDING INCLUDED OUTFLOW GRAFT COMPRESSION BY THE DRIVELINE IN 2 LOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480768 HEARTWARE LVAS VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25550 DA Hospitalization| L| R| S