BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2240835 · Received August 16, 2011

    Report

    Report Number
    2916596-2011-00360
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    May 9, 2011
    Report Date
    July 18, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR, AND THE REPORT OF RED HEART ALARMS WAS CONFIRMED AND REPRODUCED DURING THE ANALYSIS. THE EVAL OF THE RETURNED SYSTEM CONTROLLER REVEALED COMPROMISED INNER BROWN WIRES IN BOTH POWER CABLES. THE BLACK POWER CABLE WAS FOUND TO HAVE A SEVERED / BROKEN BROWN (BATTERY VOLTAGE MONITORING LINE) INNER CONDUCTOR. MOVEMENT OF THE BLACK POWER CABLE AT THE CONNECTOR END RESULTED IN LOW BATTERY AND POWER CABLE DISCONNECT ALARMS AS WELL AS INTERRUPTION IN PUMP SUPPORT WHILE CONNECTED TO THE POWER MODULE. THE EVAL OF THE WHITE POWER CABLE ALSO CONFIRMED A COMPROMISED BROWN WIRE. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MFG OR QA SPECS. THIS 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 AT THIS TIME. 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 CIRCULATORY SUPPORT SPECIALIST REPORTED THAT THE PT RECEIVED A RED HEART ALARM. THE PT SWITCHED TO THEIR BACK UP CONTROLLER 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 89363

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other