BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3102325 · Received April 30, 2013

    Report

    Report Number
    2916596-2013-00524
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 2, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND THE REPORT OF INTERMITTENT AUDIBLE ALARMS WAS CONFIRMED. VISUAL INSPECTION OF THE SYSTEM CONTROLLER CONFIRMED A SMALL TEAR IN THE BLACK POWER LEAD BUT NO WIRES WERE EXPOSED. FURTHER EVALUATION OF THE RETURNED DEVICE REVEALED COMPROMISED WIRES IN THE WHITE POWER LEAD. MOVEMENT OF THE WHITE POWER LEAD AT THE CONNECTOR END DURING FUNCTIONAL TESTING RESULTED IN HAZARDOUS LOW VOLTAGE ALARMS AS WELL AS INTERRUPTION OF PUMP FUNCTION AND TRANSITION OF THE SYSTEM CONTROLLER TO BACKUP MODE OPERATION. THE CAUSE OF THE WIRE CONDUCTOR BREAKDOWN APPEARED TO BE RELATED TO FATIGUE DUE TO REPETITIVE FLEXING IN THAT AREA DURING CLINICAL USE. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATION. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE CHIEF PERFUSIONIST REPORTED THAT THE PATIENT WAS EXPERIENCING INTERMITTENT AUDIBLE ALARMS FROM THE SYSTEM CONTROLLER. A SMALL SLIT WAS NOTICED ON THE SYSTEM CONTROLLER POWER LEAD. THE SUSPECT SYSTEM CONTROLLER WAS EXCHANGED AS PER THE INSTRUCTIONS IN THE INFORMATION FOR USE (IFU) AND THE PATIENT REMAINS ONGOING ON LVAD SUPPORT WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188746 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 115627

    Patients

    Seq Age Sex Outcome Treatment
    1 Other