BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC PVAD

    MDR report key: 2090270 · Received May 16, 2011

    Report

    Report Number
    2090270
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 3, 2011
    Report Date
    September 15, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMP; DRIVE UNIT FAILURE; DEVICE THROMBOSISADDITIONAL TEXT: RVAD > LVAD; UNABLE TO FIL PUMP ON TLC-II CONSOLE; FIBRIN STRANDS PRESENT IN BOTH BUT RVAD > LVAD; UNABLE TO FILL/ EMPTY RVADSPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION, SPECIFYADDITIONAL TEXT:OTHER COMPONENT: FIBRIN STRANDS; HIGHER PRESSURE REQUIRED TO FILL/ EMPTY PUMPCAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIEDOTHER CAUSE:INTERVENTION(S): OTHER INTERVENTIONS, SPECIFYOTHER INTERVENTION : SWITCHED TO DDCIMPLANT DEVICE TYPE: BOTH (IN THE SAME OR VISIT)MALFUNCTION DEVICE TYPE: BOTH (IN THE SAME OR VISIT)

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMP, DRIVE UNIT FAILURE, DEVICE THROMBOSISSPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION, SPECIFY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC PVAD BIVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 40.9 YR