BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3884218 · Received May 20, 2014

    Report

    Report Number
    2916596-2014-00814
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 21, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED AND RECEIVED BY THE MANUFACTURER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PT CONTACTED THE VAD COORDINATOR STATING THAT SHE HAD BEEN ON BATTERIES FOR APPROXIMATELY 18 HRS AND THOUGHT IT WAS "WEIRD" SHE HAD NOT RECEIVED A LOW BATTERY ALARM (SHE NORMALLY GETS 15-16 HRS ON BATTERY PER HER REPORT). WHEN THE PT LOOKED AT HER SYSTEM CONTROLLER IT WAS BLANK. NOTHING, INCLUDING THE GREEN ARROWS WERE ILLUMINATED AND THE PT RECEIVED NO AUDITORY ALARMS. THE PT SWITCHED HER SYSTEM CONTROLLER AT THIS POINT AND SHE REPORTED FEELING WHAT SHE THOUGHT WAS A "HEART BURN" BUT LOOKING BACK STATED IT MAY HAVE BEEN CHEST PAIN. THE VAD COORD. ON CALL MET THE PT AND GAVE HER A NEW BACKUP SYSTEM CONTROLLER. IT WAS UNDETERMINED HOW LONG THE PUMP WAS OFF. A REVIEW OF THE SUBMITTED LOG FILE DATA SHOWED A LOW ALARM (WHILE CONNECTED TO BATTERIES, A POWER CABLE DISCONNECT, AND NO EXTERNAL POWER ALARM WHERE THE EMERGENCY BACKUP BATTERY WAS IN USE, AND THE PUMP DROPPED TO 8000 RPMS, THE AUTO LOW SETTING, DUE TO POWER SAVER MODE BEING ACTIVATED. THEN IT APPEARS THE INTERNAL CLOCK/DATE WAS RESET TO 01/01/2001 AS THE BACK BATTERY BEING UNINSTALLED, THE PUMP STOPPED FOR 6 SECONDS, THEN THE WHITE CABLE FROM THE POWER MODULE WAS CONNECTED. THERE WAS THEN A YELLOW WRENCH ADVISORY FOLLOWED BY A DRIVELINE DISCONNECTED ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298627 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 106762 130918

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other