BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 23609940 · Received November 20, 2025

    Report

    Report Number
    3036773437-2025-00012
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    October 23, 2025
    Report Date
    November 20, 2025
    Manufacturer
    THERAKOS DEVELOPMENT LIMITED
    Product Code
    LNR
    UDI-DI
    20705030200003
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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-CONFORMANCE'S ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT: P303 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, CENTRIFUGE BOWL LEAK/BREAK. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. THE CUSTOMER PROVIDED PHOTOGRAPHS FOR EVALUATION. THE KIT WAS NOT RETURNED. THE CUSTOMER PROVIDED PHOTOGRAPHS SHOWED THAT THE CENTRIFUGE BOWL HAD DISLODGED FROM THE BOWL HOLDER DURING TREATMENT. A KNOWN CAUSE OF THE CENTRIFUGE BOWL DISLODGING OUT OF THE BOWL HOLDER IS THAT THE BOWL WAS NOT PROPERLY LOCKED INTO THE BOWL HOLDER DURING INSTALLATION BY THE END USER. A MATERIAL TRACE OF THE BOWL ASSEMBLY AND ITS COMPONENTS USED TO BUILD LOT: P303 FOUND NO RELATED NON-CONFORMANCE'S. THE DEVICE HISTORY RECORD (DHR) REVIEW DID NOT RESULT IN ANY RELATED NON-CONFORMANCE'S. THIS LOT PASSED ALL LOT RELEASE TESTING. THE MOST LIKELY ROOT CAUSE OF THE CENTRIFUGE BOWL LEAK/BREAK WAS DUE TO IMPROPER INSTALLATION OF THE CENTRIFUGE BOWL INTO THE BOWL HOLDER BY THE END USER. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS INVESTIGATION IS NOW COMPLETE. (B)(4) (B)(6) ON (B)(6) 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 DURING THE PROCEDURE AFTER 200MLS OF WHOLE BLOOD WAS PROCESSED. THE CUSTOMER ABORTED THE ECP TREATMENT AND NO RESIDUAL BLOOD WITHIN THE KIT WAS 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 RETURN PHOTOGRAPHS FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2468596 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS DEVELOPMENT LIMITED NA P303 20705030200003

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female