BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 14V POWER MODULE PT CABLE

    MDR report key: 2061493 · Received March 16, 2011

    Report

    Report Number
    2916596-2011-00114
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 14 VOLT POWER MODULE PT CABLE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND THE REPORTED EVENT OF CONTINUOUS ALARMS WITH A RED HEART ALARM WAS CONFIRMED. A CONTINUITY TEST WAS PERFORMED AND REVEALED THAT THERE WERE OPEN INNER CONDUCTORS ON THE WHITE POWER CABLE. UPON FURTHER EVALUATION, IT WAS NOTED THAT THE WIRE INSULATION WAS STRETCHED AND ELONGATED AND THE INNER CONDUCTORS OF ALL THE WIRES WERE FOUND DAMAGED. THE DAMAGE TO THE WIRES APPEARED TO BE MECHANICALLY INDUCED, AND APPEARED TO BE FROM TWISTING OR PULLING. THE DAMAGE OBSERVED WOULD HAVE RESULTED IN THE REPORTED RED HEART ALARMS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    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 WHILE THE PT WAS SWITCHING FROM BATTERIES TO THE POWER MODULE/POWER MODULE PT CABLE AT HOME, THE PT CONNECTED THE WHITE POWER CABLE FIRST, AND THEN, WHEN SHE DISCONNECTED THE BLACK POWER CABLE FROM THE BATTERY, SHE HEARD A CONTINUOUS TONE WITH A RED HEART ALARM. THE PT QUICKLY RECONNECTED TO BATTERIES AND ALARM WENT AWAY. THE PT'S DAUGHTER WAS PRESENT AND ATTEMPTED TO SWITCH TO THE POWER MODULE TWICE WITH THE SAME RESULTS. THE POWER MODULE PT CABLE WAS EXCHANGED AND THE ALARMS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE 14V POWER MODULE PT CABLE POWER MODULE PT CABLE (14V) DSQ THORATEC CORP 103426 34756240210

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other