BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2052137 · Received March 1, 2011

    Report

    Report Number
    2916596-2011-00078
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 4, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF POWER CABLE DISCONNECT ALARMS WAS CONFIRMED DURING ANALYSIS. POWER CABLE DISCONNECT BECAME ACTIVE WHEN THE WHITE CABLE WAS MANEUVERED. THE WHITE CABLE WAS STRIPPED AT THE CONNECTOR END, AND THE (BROWN) BATTERY GAUGE INNER CONDUCTOR WAS CONFIRMED TO BE DAMAGED. WHEN INTERRUPTED, THE BATTERY GAUGE LINE MAY RESULT IN A POWER CABLE DISCONNECT ALARM. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS SYSTEM CONTROLLER SHOWED NO DEVIATIONS FROM MFG OR QA SPECIFICATIONS. THIS SITUATION IS BEING ADDRESSED THROUGH THE MFR'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/10001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT RECEIVED "POWER CABLE DISCONNECT" ALARMS WHILE CONNECTED TO A POWER MODULE. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE EVENT 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 91588

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other