BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1860285 · Received September 22, 2010

    Report

    Report Number
    2916596-2010-00242
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    June 29, 2010
    Report Date
    August 23, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE REPORT OF ALARMS WAS CONFIRMED DURING THE EVALUATION OF SYSTEM CONTROLLER. DURING FUNCTIONAL TESTING OF THE CONTROLLER, THE "POWER CABLE DISCONNECT" ALARMS OCCURRED WHEN THE BLACK POWER LEAD WAS FLEXED AT THE CONNECTOR. FURTHER EVALUATION OF THE SYSTEM CONTROLLER REVEALED THAT THE BROWN CONDUCTOR IN THE BLACK POWER LEAD WAS BROKEN. 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 VAD COORDINATOR THAT WHILE THE PATIENT WAS IN THE REHABILITATION CENTER, HE EXPERIENCED A POWER CABLE DISCONNECT ALARM ON THE POWER MODULE. THE POWER MODULE PATIENT CABLE WAS EXCHANGED AND THINGS WERE FINE FOR A WHILE, AND THEN THERE WAS ABOUT A TWO MINUTE PERIOD OF LOW VOLTAGE, POWER CABLE DISCONNECT, AND LOW SPEED ALARMS. THE SYSTEM CONTROLLER WAS THEN EXCHANGED, THE ALARMS WERE RESOLVED. THE PATIENT REMAINS ONGOING ON THE LVAD AND NO FURTHER ISSUES WERE 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 61 YR Other