BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE SYSTEM

    MDR report key: 2191266 · Received July 19, 2011

    Report

    Report Number
    2916596-2011-00296
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 20, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT RENTAL TLC-II PLUS DRIVER WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH TWO PARACORPOREAL VADS (PVAD) FOR BIVENTRICULAR SUPPORT. THE VAD OFFICE MGR REPORTED THAT WHILE THE PT WAS EXCHANGING BATTERIES, THE RENTAL TLC-II PLUS DRIVER (DRIVER) ALARMED AND THE SCREEN WENT BLACK. IT WAS ALSO REPORTED THAT THE DRIVER WAS OVERHEATED DURING THE EVENT. THE PT'S FAMILY SUSPECTED THAT THE PUMP MAY HAVE STOPPED AS THEY DID NOT HEAR ANY NOISE FROM THE PUMP OR THE DRIVER DURING THE EVENT. THE PT'S FAMILY SUCCESSFULLY SWITCHED THE SUSPECT DRIVER TO A BACK-UP DRIVER WITH NO FURTHER ISSUE. INITIAL INSPECTION OF THE SUSPECT DRIVER BY THE HOSPITAL REPORTEDLY INDICATED THAT THE INITIAL BATTERY WAS LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE SYSTEM VENTRICULAR ASSIST DEVICE SYSTEM (TLCII) DSQ THORATEC CORP. 100621 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention