BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2001525 · Received January 27, 2011

    Report

    Report Number
    2916596-2011-00041
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    October 25, 2010
    Report Date
    January 4, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE REPORTED EVENT WAS CONFIRMED. DURING FUNCTIONAL TESTING OF THE RETURNED SYSTEM CONTROLLER, NO ALARM CONDITIONS WERE OBSERVED; HOWEVER, WHEN THE BLACK POWER LEAD WAS MANEUVERED AT THE CONNECTOR END DURING TESTING, THE SYSTEM REPORTED LOW VOLTAGE ALARMS AND A "REPLACE SYSTEM CONTROLLER ADVISORY" MESSAGE AND THEN THE PUMP STOPPED. IN ADDITION, WHEN THE SYSTEM WAS OPERATED SOLELY ON THE BLACK POWER LEAD, THE SYSTEM CONTROLLER REPORTED RED HEART AND YELLOW BATTERY ALARMS. THE SYSTEM CONTROLLER WAS DISCONNECTED FROM THE TEST SYSTEM AND UPON INSPECTION OF THE INNER CONDUCTORS AT THE CONNECTOR END OF THE BLACK POWER LEAD, THE BROWN AND BLUE WIRE CONDUCTORS WERE COMPROMISED. THIS SITUATION IS BEING ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE/PREVENTIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/10001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PATIENT WAS EXPERIENCING UNIDENTIFIED ALARMS. THE SUSPECT SYSTEM CONTROLLER WAS EXCHANGED PER THE MANUFACTURER'S INSTRUCTIONS FOR USE AND THE PATIENT REMAINS ONGOING ON LVAD SUPPORT WITH NO FURTHER ISSUE 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 31 YR Other