BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2770337 · Received October 1, 2012

    Report

    Report Number
    2916596-2012-00925
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 3, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT CONTINUES ON LVAD SUPPORT WITH NO FURTHER ISSUES REPORTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT WAS EXPERIENCING POWER ELEVATIONS. THE PT WAS ADMITTED WITH ATRIAL FIBRILLATION AND WAS PLACED ON A HEPARIN DRIP DUE TO SUSPECTED HEMOLYSIS. THE VAD COORDINATOR ALSO REPORTED THAT THE STAFF NURSE SAW THE POWER GO UP WITH SUBSEQUENT FLOW +++. THE PT WAS GIVEN 500CC OF NORMAL SALINE AND PUMP PARAMETERS RETURNED TO NORMAL. THE PT WAS REPORTED TO BE ASYMPTOMATIC AND HEMODYNAMICS WERE WITHIN NORMAL LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 109237

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention