BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE LVAS

    MDR report key: 10017036 · Received May 1, 2020

    Report

    Report Number
    10017036
    Event Type
    Injury
    Date Received
    May 1, 2020
    Date of Event
    February 5, 2018
    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 PATIENT PRESENTS WITH HIGH WATT ALARM, HEMOGLOBINURIA, ABNORMAL LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAVEFORMS IN THE SETTING OF INTERNATIONAL NORMALIZED RATIO (INR) 2.4 AND ASPIRIN 325 MG DAILY. LACTIC ACID DEHYDROGENASE (LDH) PEAKED AT 4692, AND PLASMA HEMOGLOBIN 156. PATIENT REQUIRED HEARTWARE TO HEARTWARE EXCHANGE ON DAY 2; POST OP COMPLICATIONS INCLUDED RESPIRATORY FAILURE REQUIRING TRACH AND BACTEREMIA. HEPARIN TO COUMADIN BRIDGE WAS COMPLETED PRIOR TO DISCHARGE AND ASPIRIN 325 WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481453 HEARTWARE LVAS VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 12410 DA Hospitalization| L| R