BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3093842 · Received April 30, 2013

    Report

    Report Number
    2916596-2013-00522
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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 MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE CVOR EDUCATION COORDINATOR REPORTED THE PATIENT WAS STILL IN THE OPERATING ROOM AND HAD JUST BEEN SWITCHED FROM TETHERED TO UNTETHERED POWER WHEN A RED-HEART ALARM OCCURRED. THE OPERATING ROOM PERSONNEL ATTEMPTED TO RECONNECT THE PATIENT TO TETHERED OPERATION, BUT THE SYSTEM MONITOR WOULD NOT DISPLAY THE PUMP INFO AND READ ¿NOT RECEIVING DATA¿. SUBSEQUENTLY THE PATIENT WAS SWITCHED TO THEIR BACK-UP CONTROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187132 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 123072

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention