BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3822723 · Received February 25, 2014

    Report

    Report Number
    2916596-2014-00243
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 30, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR EVAL 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 IN THE OPERATING ROOM EXPERIENCING NEARLY CONTINUOUS LOW FLOW ALARMS AND - FLOW READINGS. POWER AND PI FLUCTUATING. NOT CORRELATING WITH PTS SWAN FLOWS OR THE HEMODYNAMIC PICTURE. THE SYSTEM CONTROLLER WAS EXCHANGED WITH ANOTHER SYSTEM CONTROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116731 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 106762 135763

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention