BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1963693 · Received December 21, 2010

    Report

    Report Number
    2916596-2010-00353
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    September 28, 2010
    Report Date
    December 2, 2010
    Manufacturer
    THORATEC CORPORATION
    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 AND THE REPORTED ALARMS WERE CONFIRMED DURING ANALYSIS. THE LOG FILE WAS REVIEWED AND EVENTS WERE RECORDED CONSISTENT WITH POWER INTERRUPTION TO THE SYSTEM CONTROLLER. DURING FUNCTIONAL TESTING, MOVEMENT OF THE WHITE POWER LEAD AT THE CONNECTOR END RESULTED IN INTERRUPTION IN PUMP SUPPORT WHILE TETHERED TO THE POWER MODULE. DURING FURTHER INVESTIGATION, IT WAS FOUND THAT THE BROWN CONDUCTOR (BATTERY GAUGE LINE) OF 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 SYSTEM CONTROLLER WAS CONNECTED TO THE POWER MODULE, THE POWER MODULE ALARMED AND DISPLAYED "LOW POWER ADVISORY" AND POWER CABLE DISCONNECT; HOWEVER, THE TRAINING PUMP RAN FINE. THE SYSTEM CONTROLLER SEEMS TO WORK FINE ON BATTERIES. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE ISSUE WAS RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other