BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 23822615 · Received December 16, 2025

    Report

    Report Number
    3036773437-2025-00022
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 16, 2025
    Manufacturer
    THERAKOS DEVELOPMENT LIMITED
    Product Code
    LNR
    UDI-DI
    20705030200003
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 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 P306 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT P306 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 ALARMS WERE DUE TO THE CLOTS IN THE KIT. THE ROOT CAUSE FOR THE CLOTTING OBSERVED COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. NO FURTHER ACTION IS REQUIRED AT THIS TIME. (B)(4), (B)(6)2025.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED CLOTS OBSERVED IN THE RETURN LINE WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED ALARM #17: RETURN PRESSURE ALARMS AND OBSERVED BLOOD CLOTTING IN THE RETURN LINE WHEN APPROXIMATELY 427 ML OF WHOLE BLOOD WAS PROCESSED. THE ECP TREATMENT WAS ABORTED AND RESIDUAL BLOOD WITHIN THE KIT WAS NOT RETURNED TO THE PATIENT. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT RETURN THE PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662471 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS DEVELOPMENT LIMITED NA P306 20705030200003

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female