BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 23310461 · Received October 16, 2025

    Report

    Report Number
    3036773437-2025-00003
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 17, 2025
    Report Date
    February 13, 2026
    Manufacturer
    THERAKOS DEVELOPMENT LIMITED
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 PHOTOACTIVATION MODULE 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 P238 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES RELATED TO THE COMPLAINT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT P238 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, ALARM # 8: BLOOD LEAK? (PHOTOACTIVATION CHAMBER) AND PHOTOACTIVATION MODULE LEAK. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. AT THE TIME OF THIS REPORT, THE ANALYSIS OF THE PHOTOGRAPHS, KIT, AND SMART CARD IS STILL IN PROCESS. A FINAL REPORT WILL BE FILED WHEN THE ANALYSIS IS COMPLETE. (B)(4), (B)(6) 2025.

    Additional Manufacturer Narrative · 0

    PHOTOGRAPHS WERE PROVIDED BY THE CUSTOMER FOR EVALUATION. THE COMPLAINT KIT AND SMART CARD WERE NOT RETURNED. REVIEW OF THE CUSTOMER PROVIDED PHOTOGRAPHS VERIFY THE REPORTED PHOTOACTIVATION MODULE LEAK AS A CRACK IS VISIBLE IN THE PHOTOACTIVATION MODULE, AS REPORTED BY THE CUSTOMER. A MATERIAL TRACE OF THE ILLUMINATION PLATES USED TO BUILD LOT P238 DID NOT FIND ANY RELATED NON-CONFORMANCES. A DEVICE HISTORY RECORD (DHR) REVIEW FOR KIT LOT P238 DID NOT RESULT IN ANY RELATED NON-CONFORMANCES. THIS LOT PASSED ALL LOT RELEASE TESTING. ALL PHOTOACTIVATION PLATES ARE INSPECTED PRIOR TO PACKAGING; THEREFORE, IT IS UNLIKELY THE CRACK TO THE PHOTOACTIVATION MODULE WAS PRESENT AT THE TIME OF MANUFACTURE. THE ROOT CAUSE OF THE ALARM #8: BLOOD LEAK (PHOTOACTIVATION CHAMBER) WAS MOST LIKELY DUE TO THE FLUID LEAK IN THE PHOTOACTIVATION CHAMBER. THE ROOT CAUSE OF THE PHOTOACTIVATION MODULE LEAK WAS DUE TO THE CRACK IN THE PLATE; HOWEVER, THE CAUSE OF THE CRACK COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS INVESTIGATION IS NOW COMPLETE. (B)(4) (B)(6) 2026.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A PHOTOACTIVATION MODULE LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THEY RECEIVED AN ALARM # 8: BLOOD LEAK? (PHOTOACTIVATION CHAMBER) DURING THE TREATMENT. THE CUSTOMER THEN NOTICED A LEAK WITHIN THE PHOTOACTIVATION CHAMBER. THE ECP TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER WILL RETURN THE PHOTOGRAPHS, KIT AND SMART CARD FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2743420 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS DEVELOPMENT LIMITED NA P238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female