BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 23401984 · Received October 28, 2025

    Report

    Report Number
    3036773437-2025-00006
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    September 30, 2025
    Report Date
    February 25, 2026
    Manufacturer
    THERAKOS DEVELOPMENT LIMITED
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED PHOTOGRAPHS, A VIDEO AND THE KIT FOR EVALUATION. REVIEW OF THE CUSTOMER PROVIDED PHOTOGRAPHS SHOWED THE CENTRIFUGE BOWL FILLED WITH BLOOD AND DRIVE TUBE INSTALLED IN THE CENTRIFUGE CHAMBER. BLOOD SPRAY IS VISIBLE ON THE WALLS OF THE CENTRIFUGE CHAMBER. THE DRIVE TUBE ALSO HAS BLOOD, STARTING ABOUT HALFWAY BETWEEN THE TWO BEARING STOPS. THE CUSTOMER PROVIDED VIDEO SHOWS THE DRIVE TUBE LOWER OVER MOLD WITH BLOOD VISIBLE. A VISUAL INSPECTION OF THE RECEIVED KIT FOUND BLOOD ON THE DRIVE TUBE AND CONFIRMED THAT THE DRIVE TUBE IS DAMAGED. THE DRIVE TUBE HAD SMALL CUTS WITHIN THE DRIVE TUBE. A PRESSURE TEST OF THE DRIVE TUBE CONFIRMED A LEAK DUE TO THE SMALL CUTS. A MATERIAL TRACE OF THE DRIVE TUBE ASSEMBLY AND ITS COMPONENTS USED TO BUILD LOT P132 FOUND NO RELATED NON-CONFORMANCES. THE DEVICE HISTORY RECORD (DHR) REVIEW DID NOT RESULT IN ANY RELATED NON-CONFORMANCES. THIS LOT PASSED ALL LOT RELEASE TESTING. THE MOST LIKELY ROOT CAUSE OF THE ALARM # 7: BLOOD LEAK? (CENTRIFUGE CHAMBER) WAS DUE TO THE DRIVE TUBE LEAK. THE ROOT CAUSE FOR THE DAMAGED DRIVE TUBE COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS INVESTIGATION IS NOW COMPLETE. (B)(4), (B)(6) 2026.

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS A MDR DUE TO THE REPORTABLE MALFUNCTION DRIVE TUBE 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 P132 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES RELATED TO THE COMPLAINT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT P132 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 THIS COMPLAINT CATEGORIES. AT THE TIME OF THIS REPORT, THE ANALYSIS OF THE PHOTOGRAPHS, VIDEO, SMART CARD, AND KIT IS STILL IN PROCESS. A FINAL REPORT WILL BE FILED WHEN THE ANALYSIS IS COMPLETE. (B)(4), (B)(6) 2025.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT THEY EXPERIENCED A DRIVE TUBE LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THEY RECEIVED AN ALARM #7: BLOOD LEAK? (CENTRIFUGE CHAMBER) ALARM AFTER 1529 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE CUSTOMER THEN NOTICED A LEAK COMING FROM THE DRIVE TUBE. THE TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER WILL RETURN PHOTOGRAPHS, VIDEO, THE SMART CARD AND THE KIT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2307861 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS DEVELOPMENT LIMITED NA P132

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female