BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 3873873 · Received June 5, 2014

    Report

    Report Number
    2916596-2014-00915
    Event Type
    Death
    Date Received
    June 5, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 BIVENTRICULAR SUPPORT. IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS DISCHARGED TO REHABILITATION (B)(6) 2014. THE PT DEVELOPED A FEVER, WITH INCREASED WHILE BLOOD CELL COUNT ON (B)(6) 2014. PER VAD COORDINATOR, A DRIVELINE INFECTION WAS NOTED ON THE RVAD DRIVELINE. THE PT WAS READMITTED TO (B)(6). PLAN FOR RVAD EXPLANT ON (B)(6) 2014. ADDITIONAL INFO RECEIVED THAT THE PT WAS TAKEN TO OPERATING ROOM (B)(6) 2014. NO PUMP EXCHANGE DONE. RVAD DRIVELINE SITES DEBRIDED AND PACKED WITH VANCOMYCIN GAUZE RVAD FAILING FLASH TEST. THE VAD COORDINATOR STARTED THAT THIS HAD BEEN ONGOING FOR APPROX 2 MONTHS. NO VISIBLE FIBRIN IN THE PUMP, AND NO SIGNIFICANT CHANGES WITH INCREASE TO DRIVE PRESSURE OR VACUUM WHILE ON DUAL DRIVE CONSOLE. ADDITIONAL INFO RECEIVED BY THE VAD COORDINATOR ON (B)(6) 2014 THAT THE PT WAS MADE DNR LAST WEEK AND NO FURTHER SURGERIES PER THE PT/FAMILY WISHES. THE PT EXPIRED (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328628 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM DSQ: VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 14086-2550-000 132794

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death