BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 23194512 · Received October 1, 2025

    Report

    Report Number
    3036773437-2025-00001
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 4, 2025
    Report Date
    December 12, 2025
    Manufacturer
    THERAKOS DEVELOPMENT LIMITED
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE KIT AND SMART CARD FOR EVALUATION. SMART CARD DATA SHOWED A PRIME WAS COMPLETED AND A TREATMENT IN SINGLE NEEDLE MODE THAT WAS ENDED BEFORE EARLY PHOTOACTIVATION WAS INITIATED. DURING THE PRIME, AN ALARM #43: PRIME 10 ALARM OCCURRED, AND DURING THE TREATMENT MULTIPLE ALARM #17: RETURN PRESSURE AND ALARM #16: COLLECT PRESSURE ALARMS OCCURRED. A VISUAL INSPECTION OF THE RECEIVED KIT SHOWED BLOOD ON THE EXTERIOR OF THE RECIRCULATION PUMP TUBING SEGMENT, WHICH WAS ON TOP OF A VISIBLE HOLE IN THE TUBING. A PRESSURE TEST CONFIRMED THE PRESENCE OF A LEAK FROM THE HOLE. THE HOLE IN THE RECIRCULATION PUMP TUBING SEGMENT COULD NOT HAVE BEEN MADE DURING KIT MANUFACTURING, AS PRESSURE TESTING OF THE ASSEMBLED KITS WOULD HAVE FOUND A LEAK. TESTING OF THE RECEIVED KIT DID NOT FIND ANY MANUFACTURING ISSUES. THE MOST LIKELY ROOT CAUSE OF THE LEAK/HOLE IN THE RECIRCULATION PUMP TUBING SEGMENT OCCURS WHEN THE END USER DOES NOT INSTALL THE PUMP TUBING SEGMENT PROPERLY ONTO THE PUMP HEAD. NO FURTHER ACTION IS REQUIRED AT THIS TIME. (B)(6).

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS A MDR DUE TO THE REPORTABLE MALFUNCTION, TUBING 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: N302 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCE'S ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT: N302 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, TUBING LEAK. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. THIS ASSESSMENT IS BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. AT THE TIME OF THIS REPORT, THE ANALYSIS OF THE RETURNED KIT IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE ANALYSIS IS COMPLETE. (B)(4). (B)(6) ON (B)(6) 2025.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A TUBING LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE LEAK OCCURRED AT THE LOCATION OF THE RECIRCULATION PUMP TUBING AFTER 1500ML OF WHOLE BLOOD WAS PROCESSED. THE CUSTOMER ENDED THE ECP TREATMENT AND RETURNED BLOOD FROM THE TREATMENT BAG AND RETURN BAG TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER WILL RETURN THE KIT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836781 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS DEVELOPMENT LIMITED NA N302

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female