BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14V POWER MODULE PATIENT CABLE

    MDR report key: 2801423 · Received October 18, 2012

    Report

    Report Number
    2916596-2012-00977
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    July 5, 2012
    Report Date
    September 24, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF THE PT EXPERIENCED A YELLOW WRENCH ALARM ON THE POWER MODULE WHILE BEING SUPPORTED BY THE RETURNED 14V POWER MODULE PT CABLE WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED 14V PT CABLE REVEALED TEARS IN THE OUTER JACKET OF THE 18-FOOT SECTION OF THE CABLE THAT CONNECTS TO THE POWER MODULE, THE WHITE POWER LEAD, AND THE BLACK POWER LEAD. THE OUTER JACKET OF THE BLACK POWER LEAD AND WHITE POWER LEADS WAS REMOVED. EXAMINATION OF THE UNDERLYING WIRES FOUND THAT THE BRAIDED SHIELD BENEATH THE INSULATION WAS PARTIALLY DISRUPTED. THE EXAMINATION OF THE WIRES WITHIN THE 18 FT SECTION OF THE CABLE REVEALED A BREACH IN THE INSULATION OF THE INTERNAL WIRE REPRESENTING THE POWER LINE. THIS BREACH IN THE WIRE INSULATION ALLOWED THE INNER CONDUCTORS TO SHORT TO THE BRAIDED SHIELD, WHICH RESULTED IN THE RED HEART ALARMS ON THE SYSTEM CONTROLLER, YELLOW WRENCH ON THE POWER MODULE, AND INTERRUPTION IN PUMP FUNCTION. THE BREACH IN THE INSULATION APPEARED TO BE RELATED TO FATIGUE DUE TO REPETITIVE FLEXING DURING USE. THE POWER MODULE AND AC POWER CORD WERE FUNCTIONALLY TESTED WITH THE USE OF THE EQUIPMENT IN OUR LAB AND BOTH WERE FOUND TO FUNCTION AS INTENDED. NO FURTHER INFO IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE VAD COORDINATOR REPORTED THAT THE POWER MODULE SHOWED A YELLOW WRENCH ALARM. THE BATTERY WAY REPLACED, BUT THE ALARM CONTINUED. A 14V POWER MODULE PT CABLE WAS RETURNED FOR INVESTIGATION. DURING THE INVESTIGATION OF THE PRODUCTS, IT WAS DISCOVERED THAT THE 14V POWER MODULE PT CABLE HAD INNER CONDUCTOR BREAKDOWN WHICH CAUSED A RED HEART ALARM AND STOPPED THE PUMP WHEN THE CABLE WAS MANEUVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 14V POWER MODULE PATIENT CABLE DSQ: POWER MODULE PATIENT CABLE DSQ THORATEC CORP. 103426 34756240210

    Patients

    Seq Age Sex Outcome Treatment
    1