BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HVAD PUMP IMPLANT KIT (ENHANCED)

    MDR report key: 6092134 · Received November 10, 2016

    Report

    Report Number
    6092134
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 27, 2016
    Manufacturer
    HEARTWARE INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HEARTWARE DEVICE IMPLANTED IN THE LEFT VENTRICULAR APEX. AFTER SEPARATION OF BYPASS, THE ENERGY VS FLOW OF THE DEVICE DID NOT CORRELATE. THERE WAS CONCERN FOR THROMBUS OR MATERIAL IN DEVICE. PATIENT WAS THEN PLACED BACK ON BYPASS AND THE DEVICE WAS EXPLANTED FOR EVALUATION. WE DID NOT FIND ANY SPECIFIC REASON FOR MALFUNCTION. AN ADDITIONAL BACK TABLE TEST WAS PERFORMED AND THE DEVICE DID NOT PASS. THE NEW DEVICE WAS IMPLANTED AND THE PATIENT WAS WEANED FROM BYPASS. THE OLD DEVICE WAS TAKEN BACK TO THE HEARTWARE COMPANY BY THE HEARTWARE TECHNICIANS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744334 HVAD PUMP IMPLANT KIT (ENHANCED) VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE INC. 1103

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening| R NO