BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLC-II PORTABLE VAD DRIVER

    MDR report key: 360372 · Received November 1, 2001

    Report

    Report Number
    2916596-2001-00029
    Event Type
    Malfunction
    Date Received
    November 1, 2001
    Date of Event
    September 13, 2001
    Report Date
    November 1, 2001
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Removal / Correction Number
    2916596-10/3/01-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TLC-II VAD DRIVER SWITCHED TO EMERGENCY MODE OF PUMPING AND DISPLAYED AN ALARM MESSAGE DURING A USER TRAINING SESSION. NO PT WAS INVOLVED. THE FAILURE INVESTIGATION DETERMINED THAT THE EVENT WAS CAUSED BY A SOFTWARE DEFECT THAT WAS ALREADY UNDER INVESTIGATION DUE TO ANOMALOUS RESULTS OF IN-HOUSE TESTING. THE SOFTWARE DEFECT WAS DETERMINED TO PRESENT A REMOTE RISK TO PTS WITH ISOLATED RIGHT VENTRICULAR ASSIST DEVICE SUPPORT. THE DEFECT DOES NOT PRESENT ANY RISK TO PTS WITH LEFT VENTRICULAR ASSIST DEVICE OR CENTRIFUGAL LEFT AND RIGHT VENTRICULAR ASSIST DEVICE SUPPORT. A PRODUCT SAFETY ALERT WAS SENT TO ALL KNOWN USERS OF TLC-II VAD DRIVERS WITH VERSION 4.03 OF THE EMBEDDED SOFTWARE (FIRMWARE). THIS CORRECTIVE ACTION WAS REPORTED TO FDA'S DISTRICT OFFICE AS REPORT NO. 2916596-10/13/01-001-C. UPGRADING TLC-II DRIVERS WITH REVISED FIRMWARE, VERSION 4.11, WILL COMMENCE UPON FDA APPROVAL OF A PMA SUPPLEMENT, P870072/S18.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48954 TLC-II PORTABLE VAD DRIVER VENTRICULAR ASSIST DEVICE, PNEUMATIC DRIVER DSQ THORATEC CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA