BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2012168 · Received February 1, 2011

    Report

    Report Number
    2916596-2011-00043
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    October 14, 2010
    Report Date
    January 5, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE REPORTED EVENT WAS CONFIRMED. FUNCTIONAL TESTING OF THE RETURNED SYSTEM CONTROLLER REVEALED THAT WHEN THE BLACK POWER LEAD WAS MANIPULATED AT THE CONNECTOR END DURING TESTING, THE PUMP STOPPED, THE POWER MODULE SOUNDED A CONTINUOUS AUDIO ALARM AND THE RED AND YELLOW BATTERY LEDS ON THE SYSTEM CONTROLLER WERE ILLUMINATED. 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 CONDUCTOR THAT MONITORS THE BATTERY VOLTAGE WAS FOUND TO BE SEVERED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THIS SITUATION IS BEING ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE 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 LOW VOLTAGE AND POWER CABLE DISCONNECT 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 57 YR Other