BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1882743 · Received October 13, 2010

    Report

    Report Number
    2916596-2010-00259
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 15, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR EVAL. THE REPORTED EVENT WAS CONFIRMED DURING EVAL OF THE SYSTEM CONTROLLER. THE LOG FILE WAS REVIEWED, AND IT APPEARED THAT THE PUMP STOPPED DURING EVENTS WHERE IT WAS NOT PURPOSELY PROMPTED TO DO SO. DURING FUNCTIONAL TESTING OF THE SYSTEM CONTROLLER, THE "POWER CABLE DISCONNECT" ALARMS OCCURRED WHEN THE WHITE POWER LEAD WAS MANEUVERED AT THE CONNECTOR END OF THE LEAD. FURTHER EVAL OF THE SYSTEM CONTROLLER REVEALED THAT THE BROWN CONDUCTOR IN THE WHITE POWER LEAD WAS BROKEN. THIS SITUATION IS BEING ADDRESSED THROUGH THE MFR'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/10001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT WHEN THE PT SWITCHED FROM BATTERIES TO THE POWER MODULE, THE PT RECEIVED A YELLOW WRENCH ALARM AND FELT SYMPTOMATIC. THE PT IMMEDIATELY SWITCHED BACK TO BATTERIES AND FELT FINE. THE FOLLOWING DAY THE PT'S SYSTEM CONTROLLER WAS EXCHANGED AT THE HOSPITAL WITHOUT INCIDENT. THE PT REMAINS ONGOING ON THE LVAD AND NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other