BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1963694 · Received December 21, 2010

    Report

    Report Number
    2916596-2010-00356
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    August 10, 2010
    Report Date
    November 23, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR EVAL AND THE REPORTED EVENT WAS CONFIRMED. FUNCTIONAL TESTING OF THE RETURNED SYSTEM CONTROLLER USING A MOCK LOOP SET UP WITH A TEST PUMP REVEALED THAT IT FUNCTIONED AS INTENDED WITH NO ALARM CONDITIONS OBSERVED, EVEN WHEN THE POWER LEAD CABLES WERE MANEUVERED. IN ADDITION, THE WHITE AND BLACK POWER CABLES WERE INDEPENDENTLY DISCONNECTED AND THE SYSTEM CONTINUED TO OPERATE PROPERLY. REVIEW OF THE LOG FILE DATA IDENTIFIED A NOTABLE NUMBER POWER CABLE DISCONNECT ALARM CONDITIONS CAPTURED. INSPECTION OF THE INNER CONDUCTORS AT THE CONNECTOR END OF THE WHITE POWER LEAD WAS UNREMARKABLE; HOWEVER, THE BLACK POWER LEAD REVEALED THAT THE BROWN CONDUCTOR THAT MONITORS THE BATTERY VOLTAGE WAS KINKED AND THE WIRE BROKE WHEN A SMALL AMOUNT OF FORCE WAS APPLIED. THE COMPROMISED BROWN CONDUCTOR IN THE BLACK POWER LEAD MOST LIKELY CAUSED THE REPORTED AUDIBLE ALARMS. 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 (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT WAS EXPERIENCING UNIDENTIFIED AUDIBLE ALARMS FROM THE SYSTEM CONTROLLER. THE SUSPECT SYSTEM CONTROLLER WAS EXCHANGED PER THE MFR'S INSTRUCTIONS FOR USE AND THE PT REMAINS ONGOING ON LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 103696 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other