BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 25216201 · Received May 19, 2026

    Report

    Report Number
    3036773437-2026-00046
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 19, 2026
    Manufacturer
    THERAKOS DEVELOPMENT LIMITED
    Product Code
    LNR
    UDI-DI
    20705030200003
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS AN MDR DUE TO THE REPORTABLE MALFUNCTION ALARM #7: BLOOD LEAK (CENTRIFUGE CHAMBER). SINCE THIS REPORTABLE MALFUNCTION IS ASSOCIATED ONLY WITH THE KIT, THIS MDR WILL BE ONLY AGAINST THE KIT. A BATCH RECORD REVIEW FOR KIT LOT P328 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT P328 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES ALARM #7: BLOOD LEAK (CENTRIFUGE CHAMBER) AND DRIVE TUBE LEAK/BREAK. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. 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). (B)(6) 2026.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED THERAKOS TO REPORT AN ALARM #7: BLOOD LEAK (CENTRIFUGE CHAMBER) AND A DRIVE TUBE LEAK/BREAK THAT OCCURRED WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. LESS THAN APPROXIMATELY 1425 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. METAL SHAVINGS WERE NOTED IN THE BOTTOM OF THE CENTRIFUGE CHAMBER. THE CUSTOMER HAS DISCARDED THE KIT BUT HAS RETURNED PHOTOGRAPHS FOR EVALUATION. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618354 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS DEVELOPMENT LIMITED NA P328 20705030200003

    Patients

    Seq Age Sex Outcome Treatment
    1