BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 24953200 · Received April 22, 2026

    Report

    Report Number
    3036773437-2026-00038
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    April 8, 2026
    Report Date
    April 22, 2026
    Manufacturer
    THERAKOS DEVELOPMENT LIMITED
    Product Code
    LNR
    UDI-DI
    00705030000005
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS A MDR DUE TO THE REPORTABLE MALFUNCTION DRIVE TUBE LEAK/BREAK. 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 P250 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES RELATED TO THE COMPLAINT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT P250 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, DRIVE TUBE LEAK/BREAK. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. AT THE TIME OF THIS REPORT, THE COMPLAINT INVESTIGATION IS STILL IN PROCESS. A FINAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. (B)(4) (B)(6) 2026.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A DRIVE TUBE LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") OCCURRING AFTER AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED 1500 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE CUSTOMER ALSO REPORTED THE PATIENT WAS IN STABLE CONDITION AFTER TREATMENT. THE CUSTOMER PROVIDED PHOTOGRAPHS AND THE KIT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604264 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS DEVELOPMENT LIMITED NA P250 00705030000005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown