BEUDAMED
    FDA Adverse Event Other Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 315015 · Received February 2, 2001

    Report

    Report Number
    2916596-2001-00002
    Event Type
    Other
    Date Received
    February 2, 2001
    Date of Event
    January 5, 2001
    Manufacturer
    THORATEC LABORATORIES CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE USER INDICATED ON A THORATEC MEDICAL DEVICE TRACKING FORM THAT THE RIGHT VENTRICULAR ASSIST DEVICE (RVAD) ON THE PATIENT WAS REPLACED DUE TO FIBRIN CLOTS ON THE BLOOD SAC. THE PT WAS ON BIVENTRICULAR ASSIST DEVICE (BIVAD) SUPPORT FOR 30 DAYS. THE VAD WILL BE RETURNED TO THORATEC FOR FURTHER INVESTIGATION. ANY NECESSARY CORRECTIVE ACTION WILL BE DETERMINED UPON COMPLETION OF THE FAILURE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4411 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM VENTRICULAR ASSIST DEVICE (VAD) BLOOD PUMP DSQ THORATEC LABORATORIES CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other