BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 23732725 · Received December 5, 2025

    Report

    Report Number
    3036773437-2025-00019
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 11, 2025
    Report Date
    December 5, 2025
    Manufacturer
    THERAKOS DEVELOPMENT LIMITED
    Product Code
    LNR
    UDI-DI
    20705030200003
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 OF THE CLOT OBSERVED IN THE RETURN LINE. 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 P335 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES RELATED TO THE COMPLAINT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT P335 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, ALARM #17: RETURN PRESSURE AND CLOT OBSERVED. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. NO PRODUCT WAS RETURNED FOR EVALUATION. SECTION 2-9 OF THE CELLEX OPERATORS' MANUAL (1470493 REV 6) FOR USE WITH SOFTWARE 5.4 ON ANTICOAGULANT STATES "CAUTION: INDIVIDUAL PATIENTS MAY REQUIRE A HEPARIN DOSAGE THAT VARIES FROM THE RECOMMENDED DOSE TO PREVENT POST-TREATMENT BLEEDING OR CLOTTING DURING A TREATMENT. THE PHYSICIAN SHOULD REVIEW THE PATIENT'S MEDICAL CONDITION, MEDICATIONS AND PLATELET COUNT AT THE TIME OF TREATMENT AND USE CLINICAL JUDGEMENT TO ESTABLISH THE OPTIMAL HEPARIN DOSAGE FOR EACH PATIENT." THE ROOT CAUSE OF THE ALARM #17: RETURN PRESSURE ALARM AND THE CLOTS IN THE KIT 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) 2025.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED THERAKOS TO REPORT BLOOD CLOTTING IN THE RETURN LINE WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED AN ALARM #17: RETURN PRESSURE ALARM OCCURRED, AND THEY OBSERVED BLOOD CLOTS IN THE RETURN LINE AFTER 776 MLS 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 RETURNED PHOTOGRAPHS FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2168342 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS DEVELOPMENT LIMITED NA P335 20705030200003

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male