BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLC-II PORTABLE VAD DRIVER

    MDR report key: 398257 · Received May 31, 2002

    Report

    Report Number
    2916596-2002-00018
    Event Type
    Malfunction
    Date Received
    May 31, 2002
    Date of Event
    April 4, 2002
    Report Date
    May 29, 2002
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    2916596-10/3/01-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A BIVAD PATIENT WITH THORATEC VAD ON RIGHT WAS SWITCHED FROM THE DUAL DRIVE CONSOLE (DDC) TO THE TLC-II PORTABLE DRIVER. APPROXIMATELY 15 MINUTES LATER, THE DRIVER BEGAN MAKING A NOISE FROM INSIDE THE COMPRESSOR AND THE TLC-II DISPLAYED AN ALARM MESSAGE. THE PATIENT WAS SWITCHED TO A BACK-UP TLC-II WITHOUT INCIDENT. 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 PATIENTS WITH ISOLATED RVAD 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). UPGRADING THE TLC-II DRIVERS WITH REVISED FIRMWARE, VERSION 4.11, BEGAN UPON FDA APPROVAL OF PMA SUPPLEMENT P870072/S18 ON APRIL 18, 2002.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention