BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS XTS SYSTEM

    MDR report key: 3915467 · Received June 5, 2014

    Report

    Report Number
    2523595-2014-00155
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT B725 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES RELATED TO THIS TYPE OF FAILURE FOR THIS LOT. LOT MET RELEASE REQUIREMENTS. TRENDS HAVE BEEN REVIEWED FOR THIS COMPLAINT CATEGORY AND NO TREND HAS BEEN DETECTED. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION AT THE TIME OF THIS REPORT; THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECIFICATION BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A LEAK AT THE HEMATOCRIT CUVETTE AT THE START OF THE FIRST BUFFY COAT COLLECTION. TREATMENT WAS ABORTED. PATIENT WAS SET UP ON ANOTHER KIT, AND PROCEDURE IS RUNNING SMOOTHLY AT THE TIME OF THE CALL. CUSTOMER OPTED NOT TO RETURN THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328857 THERAKOS XTS SYSTEM LNR THERAKOS INC. B725-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR