BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2163512 · Received June 2, 2011

    Report

    Report Number
    2916596-2011-00228
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    March 22, 2011
    Report Date
    May 9, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVAL. THE SYSTEM CONTROLLER WAS CONNECTED TO THE EQUIPMENT IN THE MFR'S LAB WITH NO ALARMS ACTIVE. THE BLACK AND WHITE POWER CABLES WERE MANEUVERED AND WHILE MOVING THE WHITE POWER CABLE AT THE CONNECTOR END, THE "POWER CABLE DISCONNECT" AND "RED BATTERY" ALARM BECAME ACTIVE. THE SYSTEM CONTROLLER WAS THEN CONNECTED TO A POWER MODULE AND WHILE MOVING THE WHITE POWER CABLE, SUPPORT TO THE PUMP COULD BE INTERRUPTED. THE WHITE POWER CABLE WAS THEN STRIPPED AT THE CONNECTOR END REVEALING A BROKEN INNER CONDUCTOR. 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.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT'S SYSTEM CONTROLLER LIGHTS ALL WENT OFF AND UNK ALARMS WERE OBSERVED. IT WAS ALSO REPORTED THAT THEY WERE UNABLE TO DOWNLOAD HISTORY. THE SYSTEM CONTROLLER WAS EXCHANGED FOR ANOTHER SYSTEM CONTROLLER AND NO FURTHER PROBLEMS 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 87390

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other