BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 23839447 · Received December 18, 2025

    Report

    Report Number
    3036773437-2025-00023
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 18, 2025
    Manufacturer
    THERAKOS DEVELOPMENT LIMITED
    Product Code
    LNR
    UDI-DI
    20705030200003
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 P305 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT P305 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, CENTRIFUGE BOWL LEAK/BREAK. 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. THE MANUFACTURER PERFORMED AN INVESTIGATION BASED ON THE AVAILABLE INFORMATION, INCLUDING A REVIEW OF THE INTERVIEW WITH THE COMPLAINANT (I.E., COMPLAINT DESCRIPTION), DEVICE BATCH RECORD FOR NON-CONFORMANCES, DEVIATIONS OR EQUIPMENT MAINTENANCE EVENTS RELATED TO THE COMPLAINT, COMPLAINT CATEGORY, AND DEVICE BATCH SPECIFIC TRENDING. IN ADDITION, A THERAKOS FIELD SERVICE ENGINEER WAS DISPATCHED TO PERFORM INSTRUMENT SERVICE AS A RESULT OF THE COMPLAINT. A REVIEW OF THE SERVICE DETAILS VERIFIED THE REPORTED COMPLAINT; HOWEVER, NO CONTRIBUTING FACTORS FOR THE REPORTED COMPLAINT WERE IDENTIFIED. 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). (B)(6). 18 DEC 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 THE CENTRIFUGE BOWL BROKE AFTER 100ML OF WHOLE BLOOD HAD BEEN PROCESSED. 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. NO PRODUCT WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244518 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS DEVELOPMENT LIMITED NA P305 20705030200003

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male