BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 8883058 · Received August 12, 2019

    Report

    Report Number
    8883058
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    October 13, 2018
    Report Date
    July 24, 2019
    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) PRESENTS 9 MONTHS POSTOPERATIVELY WITH HIGH WATT ALARMS, HEMOGLOBINURIA, LACTATE DEHYDROGENASE (LDH) 3315/ HAPTOGLOBIN <10 IN THE SETTING OF INTERNATIONAL NORMALIZED RATIO (INR) 2.3. PT PRESENTED 3 DAYS AFTER SYMPTOMS STARTED DUE TO TRANSPORTATION ISSUES / PT PREFERENCE. HEARTWARE TO HEARTWARE SURGICAL EXCHANGE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679392 HEARTWARE VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27375 DA Hospitalization| L| R| S