BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3813265 · Received March 28, 2014

    Report

    Report Number
    2916596-2014-00448
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    February 28, 2014
    Report Date
    February 28, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. NO FURTHER INFORMATION 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT PRESENTED TO THE ED AND REPORTED THAT HE HAD A RED HEART ALARM WHILE SWITCHING FROM BATTERY POWER TO TETHERED SUPPORT (CONNECTING TO POWER MODULE). THE WHITE CABLE WAS CONNECTED AT THE TIME AS THE PATIENT HAD DISCONNECTED THE BLACK CABLE FROM THE BATTERY TO ATTACH TO HIS POWER MODULE. THE PATIENT HAD EXCHANGED HIS SYSTEM CONTROLLER AT HOME. IT WAS REPORTED THAT THERE WAS NO VISIBLE DAMAGE NOTED TO THE SUSPECT SYSTEM CONTROLLER, CABLES, AND PINS. THE WHITE COATING SURROUNDING THE PATIENT'S DRIVELINE HAD SLOWLY BROKEN DOWN AND WAS COVERED WITH RED RESCUE TAPE. THE TAPE STARTS NEAR THE EXIT SITE AND GOES UP TO THE SYSTEM CONTROLLER. THERE WERE SOME AREAS WHERE THE TAPE HAD FALLEN OFF AND THE WHITE COATING WAS IN SHREDS. THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR FURTHER EVALUATION. THE PATIENT HAD SUBTHERAPEUTIC INR AT THE TIME (1.6), AND IT HAD BEEN THERAPEUTIC FOR A COUPLE OF MONTHS PRIOR TO THE EVENT. THERE WERE NO ELEVATIONS IN THE PATIENT'S HEMOLYZING STUDIES FROM THE BEGINNING OF THE MONTH. THE PATIENT IS IN THE HOSPITAL FOR FURTHER WORK-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184826 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1355 77316

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other