BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2180738 · Received May 5, 2011

    Report

    Report Number
    2916596-2011-00181
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    November 23, 2010
    Report Date
    April 6, 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 MFR FOR EVAL AND THE REPORTED EVENT WAS CONFIRMED. THE SYSTEM CONTROLLER WAS CONNECTED TO A TEST PT CABLE, POWER MODULE, SYSTEM MONITOR. THE LOG FILE WAS RETRIEVED SUCCESSFULLY. AN LVAD TEST PUMP WAS CONNECTED AND THE SYSTEM BEGAN RUNNING AT 1000 RPM'S WITH NO ALARMS ACTIVE. THE BLACK AND WHITE POWER CABLES WERE MANEUVERED AND WHILE MOVING THE BLACK POWER CABLE AT THE CONNECTOR END, THE CONTROLLER SOUNDED ALARMS AND THE PUMP STOPPED. THE SYSTEM CONTROLLER WAS DISCONNECTED TO DO A CONTINUITY CHECK ON BOTH POWER CABLES. THE BLACK POWER CABLE HAD A HIGH RESISTANCE ON THE BROWN (RSOC) INNER WIRE. THE WHITE POWER CABLE PASSED CONTINUITY CHECK. THE OUTER INSULATION AT THE CONNECTOR ENDS OF BOTH POWER CABLES WAS REMOVED EXPOSING THE INNER WIRES. THE BLACK POWER CABLE REVEALED A COMPROMISED BROWN (RSOC) INNER CONDUCTOR. THE INNER CONDUCTORS IN THE WHITE POWER CABLE WERE INTACT. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MFG OR QA SPECIFICATIONS. THE SITUATION IS BEING ADDRESSED THROUGH THE MFR'S CORRECTIVE/PREVENTIVE 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). THE VAD COORDINATOR REPORTED THAT THE SYSTEM CONTROLLER RECEIVED YELLOW BATTERY ALARMS WHEN THE BATTERIES THAT WERE BEING USED WERE FULLY CHARGED. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE PT 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 92807

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other