BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC PVAD

    MDR report key: 2210828 · Received August 12, 2011

    Report

    Report Number
    2210828
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    August 8, 2011
    Report Date
    March 14, 2012
    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 PUMPSPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION, SPECIFY

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMP.ADDITIONAL TEXT: UNABLE TO OBTAIN A FILL SIGNAL DESPITE MANY FILL CABLES, CONSOLE CHANGES.SPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION, SPECIFY.ADDITIONAL TEXT:OTHER COMPONENT: UANBLE TO LOCATE DEFINITIE CAUSE COULD BE HALL SWITCH OR INTERNAL WIRING.CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED.OTHER CAUSE:INTERVENTION(S): OTHER INTERVENTIONS, SPECIFY.OTHER INTERVENTION : PUT DEVICE IN FIXED MODE.IMPLANT DEVICE TYPE: BOTH (IN THE SAME OR VISIT).MALFUNCTION DEVICE TYPE: BOTH (IN THE SAME OR VISIT).

    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 61.6 YR