BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 23312769 · Received October 16, 2025

    Report

    Report Number
    3036773437-2025-00004
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 16, 2025
    Manufacturer
    THERAKOS DEVELOPMENT LIMITED
    Product Code
    LNR
    UDI-DI
    20705030200003
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS A MDR DUE TO THE REPORTABLE MALFUNCTION PRESSURE DOME LEAK. SINCE THIS REPORTABLE MALFUNCTION IS ONLY ASSOCIATED WITH THE KIT, THIS MDR WILL ONLY BE AGAINST THE KIT. A BATCH RECORD REVIEW FOR KIT LOT N350 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES RELATED TO THE COMPLAINT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT N350 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, PRESSURE DOME LEAK, ALARM #53: RETURN LINE AIR DETECTED AND CLOT OBSERVED. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. THE SMART CARD AND KIT WERE RETURNED FOR EVALUATION. THE KIT WAS RETURNED AND A VISUAL INSPECTION FOUND DRIED BLOOD ON THE OUTSIDE OF THE RETURN PRESSURE DOME. THERE WAS NO EVIDENCE OF BLOOD SOLIDS IN THE FILTER OR CENTRIFUGE CHAMBER. A PRESSURE TEST WAS PERFORMED ON THE RETURN CIRCUIT AND A LEAK WAS FOUND IN THE RETURN PRESSURE DOME. ALL CELLEX KITS ARE LEAK TESTED PRIOR TO PACKAGING. A LEAK OF THIS NATURE WOULD HAVE BEEN DETECTED DURING IN-PROCESS TESTING; THEREFORE, IT IS UNLIKELY THE PRESSURE DOME LEAKED AT THE TIME OF MANUFACTURE. THE REPORTS OF CLOTS WITHIN THE KIT WAS NOT CONFIRMED UPON REVIEW. THE ROOT CAUSE FOR THE PRESSURE DOME LEAK COULD NOT BE DETERMINED. NO FURTHER ACTION IS REQUIRED AT THIS TIME. (B)(4). H.M. 16 OCT 2025.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED THERAKOS TO REPORT AN ALARM #53: RETURN LINE AIR DETECTED ALARM AND BLOOD CLOTTING OBSERVED WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THEY OBSERVED AIR IN THE RETURN LINE AND A BLOOD CLOT WAS SEEN IN THE FILTER OF THE KIT DURING THE ECP TREATMENT. THE ECP TREATMENT WAS ABORTED AND RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE COMPLAINT KIT WAS RETURNED FOR INVESTIGATION. EVALUATION OF THE RETURNED KIT FOUND BLOOD RESIDUE ON THE OUTSIDE OF THE RETURN PRESSURE DOME. THIS FINDING MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION AS THE PRESSURE DOME LEAK MOST LIKELY OCCURRED DURING THE ECP TREATMENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE COMPLAINT KIT AND SMART CARD WERE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2375249 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS DEVELOPMENT LIMITED NA N350 20705030200003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male