BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC TLC-II PLUS PORTABLE DRIVER

    MDR report key: 7821361 · Received August 27, 2018

    Report

    Report Number
    2916596-2018-03238
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Date of Event
    August 2, 2018
    Report Date
    June 17, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P870072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: ADDITIONAL INFORMATION. DEVICE MANUFACTURE DATE: ADDITIONAL INFORMATION. MANUFACTURER INVESTIGATION CONCLUSION: THE REPORTED EVENT, OF THE THORATEC TLC-II PLUS PORTABLE DRIVER NOT STARTING UP PROPERLY, WAS CONFIRMED. A FAULTY MECHANICAL KEYSWITCH IN THE KEYSWITCH HARNESS ASSEMBLY WAS FOUND. THE FAULTY KEYSWITCH ESSENTIALLY ELECTRICALLY SHORTED THE EXTERNAL POWER INPUT (AC ADAPTER) TO GROUND WHEN THE AC ADAPTER WAS INSTALLED IN THE TLC-II DRIVER. HOWEVER, THE TLC-II DRIVER STARTED UP PROPERLY WHEN ONLY BATTERIES WERE USED AS ITS ONLY POWER SOURCE. THIS OCCURRED WHEN THE AC ADAPTER WAS NOT CONNECTED TO THE TLC-II DRIVER. THE LOG FILE FOR THE TLC-II DRIVER CONFIRMED THAT FAILURE. THE KEYSWITCH WAS INSTALLED INTO THE DRIVER WHEN IT WAS ORIGINALLY BUILT ¿ APPROXIMATELY 15 YEARS AGO. EXTERNAL POWER WAS UNABLE TO POWER THE DRIVER WHEN CONNECTED ¿ BUT THE DRIVER OPERATED PROPERLY WHEN OPERATING ON BATTERY POWER ONLY. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE: THE TLC II DRIVER IS NOT A SINGLE USE DEVICE. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE EVALUATION IS NOT YET COMPLETE. THE PATIENT REMAINS ONGOING ON VAD SUPPORT. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH PARACORPOREAL VENTRICULAR ASSIST DEVICES. IT WAS REPORTED THAT THE PATIENT'S TLC II DRIVER WAS NOISY, SO IT WAS EXCHANGED FOR ANOTHER TLC II DRIVER. AFTER THE EXCHANGE, THE NEW TLC II DRIVER STOPPED THE PUMP FOR ABOUT 45 SECONDS UNTIL IT WAS CONNECTED TO A/C POWER. THE PATIENT WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662022 THORATEC TLC-II PLUS PORTABLE DRIVER VENTRICULAR ASSIST DEVICE SYSTEM (TLC-II PLUS) DSQ THORATEC CORPORATION 100621

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR