BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE LVAS

    MDR report key: 10017023 · Received May 1, 2020

    Report

    Report Number
    10017023
    Event Type
    Injury
    Date Received
    May 1, 2020
    Date of Event
    October 25, 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

    PATIENT WITH HISTORY OF HEARTWARE TO HEARTWARE EXCHANGE FOR HEMOLYSIS ~ 1.5 YEARS PRIOR, NOW PRESENTS WITH HEMOGLOBINURIA, NO VENTRICULAR ASSIST DEVICES (VAD) ALARMS INITIALLY AND NO ABNORMAL LVAD WAVEFORMS INITIALLY IN THE SETTING OF INTERNATIONAL NORMALIZED RATIO (INR) 1.7 AND ASPIRIN 325 MG DAILY. LACTIC ACID DEHYDROGENASE (LDH) PEAKED AT 2907 AND PLASMA HEMOGLOBIN 219. WITHIN 24 HOURS OF ADMISSION HIGH WATT ALARMS AND ABNORMAL WAVEFORMS WERE OBSERVED. PATIENT UNDERWENT HEARTWARE TO HEARTMATE 3 EXCHANGE. HEPARIN TO COUMADIN THERAPY WAS COMPLETED PRIOR TO ADMISSION, AND ASPIRIN 325 MG WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481270 HEARTWARE LVAS VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 12775 DA Hospitalization| L| R