BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 23610364 · Received November 20, 2025

    Report

    Report Number
    3036773437-2025-00013
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    October 23, 2025
    Report Date
    January 20, 2026
    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
    OTHER HEALTH CARE PROFESSIONAL
    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 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 N370 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT N370 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, PRESSURE DOME LEAK. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. THE ASSESSMENT IS BASED ON THE INFORMATION AVAILABLE AT THE TIME OF INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION; THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECIFICATION BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS INVESTIGATION IS NOW COMPLETE. (B)(6). (B)(6) 2025.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED BASED ON THE COMPLAINT DESCRIPTION, SMART CARD DATA AND RETURNED KIT. A REVIEW OF THE DATA ON THE RETURNED SMART CARD SHOWED MULTIPLE ALARM #16: COLLECT PRESSURE WARNINGS AND MULTIPLE ALARM #17: RETURN PRESSURE WARNINGS OCCURRED DURING A TREATMENT THAT WAS NOT COMPLETED. THE KIT WAS RETURNED INTACT AND A VISUAL INSPECTION FOUND DRIED BLOOD ON THE BODY OF THE RETURN PRESSURE DOME, WHICH WAS MISSING ITS DIAPHRAGM. THE DIAPHRAGM WAS NOT INCLUDED IN THE RETURNED KIT. A TEST DIAPHRAGM WAS INSTALLED ON TO THE RETURN PRESSURE DOME, AND A PRESSURE TEST DID NOT FIND ANY LEAKS. THE LOSS OF THE DIAPHRAGM COULD NOT HAVE BEEN AN ASSEMBLY ERROR AS FINISHED KITS ARE PRESSURE TESTED FOR LEAKS AND AN UNSEATED DIAPHRAGM WOULD HAVE BEEN FOUND DURING THAT TEST. THE MOST LIKELY ROOT CAUSE FOR THE PRESSURE DOME LEAK IS DUE TO THE PRESSURE DOME NOT BEING SECURED ONTO THE PUMP DECK DURING INSTALLATION OF THE KIT BY THE END USER. NO FURTHER ACTION IS REQUIRED AT THIS TIME. (B)(4), (B)(6) 2026.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT THEY EXPERIENCED A PRESSURE DOME LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THEY OBSERVED A LEAK AT THE PRESSURE DOME DURING THE TREATMENT AFTER 150MLS OF WHOLE BLOOD WAS PROCESSED. THE ECP TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE KIT RETURN WAS REQUESTED; HOWEVER, THE CUSTOMER WILL NOT RETURN THE KIT. THE CUSTOMER WILL NOT RETURN PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2661767 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS DEVELOPMENT LIMITED NA N370 20705030200003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown