BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 23606448 · Received November 20, 2025

    Report

    Report Number
    3036773437-2025-00010
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 19, 2025
    Manufacturer
    THERAKOS DEVELOPMENT LIMITED
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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 CENTRIFUGE BOWL 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 P303 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT P303 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, CENTRIFUGE BOWL LEAK/BREAK AND ALARM #7: BLOOD LEAK? (CENTRIFUGE CHAMBER). NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. 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)(4) N.S. 19-NOV-2025.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A CENTRIFUGE BOWL LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED AN ALARM #7: BLOOD LEAK? (CENTRIFUGE CHAMBER) ALARM AND THE CENTRIFUGE BOWL BROKE DURING THE PROCEDURE AFTER 120MLS OF WHOLE BLOOD WAS PROCESSED. THE ECP TREATMENT WAS ABORTED AND RESIDUAL BLOOD WITHIN THE KIT WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS 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
    315123 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS DEVELOPMENT LIMITED NA P303

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female