BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 6088278 · Received November 8, 2016

    Report

    Report Number
    2523595-2016-00250
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 10, 2016
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    UDI-DI
    10705030100009
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A BATCH RECORD REVIEW OF KIT LOT E205 WAS CONDUCTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. THE UVADEX LOT NUMBER WAS NOT PROVIDED AS IT WAS NOT ADMINISTERED. HOWEVER, A REVIEW OF ALL UVADEX LOTS MANUFACTURED SINCE JANUARY 2013 WAS PERFORMED. NO TRENDS OR NONCONFORMANCES RELATED TO THE COMPLAINT WERE NOTED. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, PRESSURE DOME MEMBRANE LEAK. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. SERVICE ORDER REPORT, (B)(4), FEEDBACK: THE SERVICE TECHNICIAN REMOVED THE INSTRUMENT'S PUMP DECK IN ORDER TO CHECK AND CLEAN THE PUMPS. THE SYSTEM CHECKOUT PROCEDURE WAS THEN SUCCESSFULLY COMPLETED. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION; THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECIFICATION BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED. (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A PRESSURE DOME MEMBRANE LEAK AT THE SYSTEM PRESSURE DOME AFTER 300ML OF WHOLE BLOOD PROCESSED. THE CUSTOMER STATED THAT THE TREATMENT WAS ABORTED WITH NO BLOOD/PRODUCTS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER STATED THAT THE PATIENT STARTED A NEW PROCEDURE ON A DIFFERENT INSTRUMENT. THE CUSTOMER REPORTED THAT THE LEAK WENT UNDER SOME OF THE PUMPS ON THE PUMP DECK AND REQUESTED SERVICE. THE KIT WAS NOT RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736469 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC E205-KIT 10705030100009

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR