BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2093637 · Received April 6, 2011

    Report

    Report Number
    2916596-2011-00144
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    December 28, 2010
    Report Date
    March 8, 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 MANUFACTURER FOR EVALUATION AND THE REPORTED ALARM WAS CONFIRMED DURING ANALYSIS. DURING FUNCTIONAL TESTING, THE POWER CABLE DISCONNECT ALARM OCCURRED WHEN THE BLACK POWER LEAD WAS MANEUVERED. WHEN THE SYSTEM CONTROLLER WAS RUN BY JUST THE BLACK POWER LEAD, A YELLOW BATTERY ALARM BECAME ACTIVE AND PROGRESSED TO A RED BATTERY ALARM. DURING FURTHER INVESTIGATION, IT WAS FOUND THAT THE BROWN CONDUCTOR (BATTERY GAUGE LINE) OF THE BLACK POWER LEAD WAS DAMAGED. THIS SITUATION IS BEING ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE/PREVENTATIVE 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). IT WAS REPORTED BY THE CIRCULATORY SUPPORT SPECIALIST THAT THE PATIENT EXPERIENCED A YELLOW WRENCH ALARM WHEN CONNECTED TO THE POWER MODULE. THE PATIENT WAS ABLE TO CREATE AN ALARM WHEN HE MANIPULATED THE BLACK POWER LEAD OF THE SYSTEM CONTROLLER. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE ALARM WAS RESOLVED.

    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 65 YR Other