BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2872057 · Received December 11, 2012

    Report

    Report Number
    2916596-2012-01200
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    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 THE PT WAS READMITTED FOR GASTROINTESTINAL (GI) BLEED. ONE OF THE INTENSIVE CARE UNIT (ICU) NURSES REPORTED THAT THE PT'S SYSTEM CONTROLLER WAS HOT. THE VAD COORDINATOR EXAMINED THE SYSTEM CONTROLLER AND CONFIRMED THAT THE SYSTEM CONTROLLER WAS "ON FIRE". IT WAS NOTED THAT THE PT HAD SUFFERED MILD 1ST DEGREE BURN ON HIS HIP WHERE THE SYSTEM CONTROLLER HAD BEEN RESTING. AT THE TIME OF EXAMINATION BY THE VAD COORDINATOR, THE SYSTEM CONTROLLER WAS FOUND TO BE UNCOVERED AND HAD AIR CIRCULATING AROUND IT. THE SYSTEM CONTROLLER WAS EXCHANGED WITH ANOTHER SYSTEM CONTROLLER AND NO FURTHER PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 113582

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention