BEUDAMED
    FDA Adverse Event Other Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 305260 · Received November 9, 2000

    Report

    Report Number
    2916596-2000-00029
    Event Type
    Other
    Date Received
    November 9, 2000
    Date of Event
    October 11, 2000
    Report Date
    November 9, 2000
    Manufacturer
    THORATEC LABORATORIES CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE USER INDICATED THAT A PT UNDERWENT REOPERATION TO CHANGE THE VENTRICULAR ASSIST DEVICE (VAD) DUE TO HEMOLYSIS SUSPECTED TO BE RELATED TO THE DEVICE. THE EXPLANTED VAD WAS RETURNED UNSTERILE TO THORATEC'S MFG FACILITY FOR EVAL. FURTHER INVESTIGATION OF THE DEVICE WILL BE CONDUCTED AFTER THE VAD HAS BEEN STERILIZED. ANY NECESSARY CORRECTIVE ACTION WILL BE DETERMINED UPON COMPLETION OF THE FAILURE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 UNKNOWN Other