BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3051313 · Received April 10, 2013

    Report

    Report Number
    3051313
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 3, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT IN CARDIOGENIC SHOCK. CO/CI 3.7/1.88 HM2 FLOWS 3.7 AT 10,000 (B)(6) SV02 41% LDH 1147. TAKEN TO OPERATING ROOM AND FOUND TO HAVE OCCLUSION OF INFLOW CANNULA BELIEVED TO BE CAUSED BY LA APPENDAGE THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149560 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1