BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMII SYSTEM CONTROLLER

    MDR report key: 1791445 · Received August 2, 2010

    Report

    Report Number
    2916596-2010-00198
    Event Type
    Malfunction
    Date Received
    August 2, 2010
    Date of Event
    June 8, 2010
    Report Date
    July 8, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR ANALYSIS. DURING THE EVAL, THE SYSTEM CONTROLLER ALARMED, AND THE CABLE BEGAN HEATING UP. THE TEST POWER BASE UNIT (PBU) BECAME DAMAGED BEFORE THE CONTROLLER WAS DISCONNECTED. DURING FURTHER EVAL, A BROKEN POWER LINE IN THE BLACK POWER LEAD OF THE SYSTEM CONTROLLER WAS FOUND. THE CAUSE OF THE DAMAGE WAS UNABLE TO BE CONCLUSIVELY DETERMINED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MFG OR QA SPECIFICATIONS. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT WHEN THE PT WAS CONNECTED TO THE POWER BASE UNIT (PBU) WHITE POWER CABLE IN THE CLINIC, A POWER CABLE DISCONNECT ALARM OCCURRED. WHEN THE WHITE POWER CABLE WAS DISCONNECTED, THERE WAS A STEADY TONE WITH A RED HEART AND YELLOW BATTERY ALARM. ONCE THE PT WAS CONNECTED TO BATTERY POWER, THE ALARMS STOPPED. WHEN SWITCHING THE PT BACK TO THE PBU, THE BLACK POWER LEAD BECAME HOT. THE SYSTEM CONTROLLER WAS EXCHANGED WITHOUT INCIDENT. THE PT REMAINS ONGOING ON THE LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HMII SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention