BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 5071985 · Received September 11, 2015

    Report

    Report Number
    2523595-2015-00247
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 6, 2015
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    UDI-DI
    10705030100009
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A REVIEW OF KIT LOT D325 WAS PERFORMED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET RELEASE REQUIREMENTS. THE UVADEX LOT NUMBER WAS NOT PROVIDED, SINCE UVADEX 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 PTO LEAK. NO TREND WAS IDENTIFIED FOR PTO LEAK. NO CORRECTIVE AND PREVENTIVE ACTION WAS INITIATED FOR COMPLAINT CATEGORY PTO LEAK. THE SMARTCARD AND KIT ASSOCIATED WITH THIS COMPLAINT WERE RECEIVED FOR ANALYSIS. REVIEW OF THE RETURNED KIT COMPONENTS IDENTIFIED SEVERAL COLLECT PRESSURE ALARMS WERE SEEN BUT, THE BUFFY COAT COLLECTION COMPLETED WITHOUT ANY ALARMS. A RETURN PRESSURE ALARM OCCURRED AFTER THE BUFFY COAT COLLECTION BUT, THE PHOTOACTIVATION WAS STARTED. SEVERAL RETURN PRESSURE AND AIR DETECTED ALARMS WERE SEEN. THE RETUNED RECIRCULATION PUMP TUBING SEGMENT AND PTO WERE PRESSURE TESTED UNDER WATER AND A STREAM OF VERY FINE BUBBLES EMERGED FROM THE T CONNECTOR THAT JOINS THE CLEAR AND GREEN STRIPED TUBING. THE TESTING SHOWED THAT THE LEAK WAS BETWEEN THE CLEAR TUBING AND ITS PORT ON THE T CONNECTOR. THE LEAK SITE INDICATED THAT THE CLEAR TUBING IS ONLY ABOUT HALFWAY INSERTED INTO ITS PORT ON THE T CONNECTOR AND LIKELY DID NOT FORM A COMPLETE BOND. ROOT CAUSE OF THE BLOOD LEAK IS LIKELY MANUFACTURER ERROR WHEN FORMING THE BOND BETWEEN THE CLEAR TUBING AND THE T CONNECTOR NOT FULLY INSERTING THE TUBING. MANUFACTURING OPERATOR TRAINING AND INSTRUCTION HAS BEEN PROVIDED. NC 18467 HAS BEEN OPENED FOR LATE REPORTING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FLUID LEAK UNDER THE PTO 3 MINUTES INTO PHOTOACTIVATION. CSS ADVISED THE CUSTOMER TO ABORT TREATMENT. THE CUSTOMER RETURNED THE SMART CARD AND KIT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603594 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. D325/23-KIT 10705030100009

    Patients

    Seq Age Sex Outcome Treatment
    1