BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2211966 · Received August 10, 2011

    Report

    Report Number
    2916596-2011-00354
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    April 14, 2011
    Report Date
    July 12, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION, AND THE REPORTED EVENT OF HAZARDOUS LOW FLOW CONDITIONS AND THE REVERSION TO BACK UP MODE WERE CONFIRMED IN THE LOG FILE. THE RETURNED SYSTEM CONTROLLER WAS CONNECTED TO THE POWER MODULE PT CABLE, POWER MODULE, AND SYSTEM MONITOR. THE DATA LOG FILE WAS RETRIEVED SUCCESSFULLY. PER THE LOG FILE, APPROXIMATELY 8 DAYS OF EVENTS WERE RECORDED. HAZARDOUS LOW VOLTAGE CONDITIONS ACCOMPANIED SYSTEM SUPPORT INTERRUPTIONS AND THE REVERSION TO THE BACK-UP MODE WERE CAPTURED. THE SYSTEM CONTROLLER WAS CONNECTED THE HMII TEST PUMP AND SYSTEM WAS OPERATED AT 9800 RPM'S, THE YELLOW WRENCH AND RED BATTERY WERE ACTIVATED ON THE POWER MODULE. THE BLACK AND WHITE POWER CABLES WERE MANEUVERED AT THE CONNECTOR END AND HAZARDOUS ALARMS FOR LOW VOLTAGE AS WELL AS INTERRUPTION IN PUMP SUPPORT OCCURRED. THE SYSTEM CONTROLLER WAS DISCONNECTED AND REMOVED FOR FURTHER EVALUATION. THE OUTER INSULATION AT THE CONNECTOR END OF THE BLACK POWER CABLE WAS THEN REMOVED IN ORDER TO EXPOSE THE INNER CONDUCTORS. THE BROWN CONDUCTOR WAS FOUND TO BE SEVERED AND THE YELLOW CONDUCTOR WAS COMPROMISED. ALSO, THE WHITE POWER LEAD AT THE SAME LOCATION WAS OBSERVED AND THE BROWN CONDUCTOR WAS SIGNIFICANTLY KINKED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. A CORRECTIVE ACTION IS CURRENTLY BEEN ADDRESSED THROUGH THE MANUFACTURE'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 AT THIS TIME. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT WAS AT HOME RECEIVING A RED LIGHT AND YELLOW WRENCH ON THE POWER MODULE CONTROLLER WENT INTO BACK UP MODE. THE SYSTEM CONTROLLER WENT INTO BACK UP MODE. THE SYSTEM CONTROLLER WAS EXCHANGED 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 CORPORATION 103696 86457

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other