BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 25056306 · Received May 1, 2026

    Report

    Report Number
    3036773437-2026-00044
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 1, 2026
    Manufacturer
    THERAKOS DEVELOPMENT LIMITED
    Product Code
    LNR
    UDI-DI
    00705030000005
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 P234 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS COMPLAINT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT P234 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES ALARM #16: COLLECT PRESSURE, ALARM #17: RETURN PRESSURE AND CLOT OBSERVED. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. SECTION 2-9 OF THE CELLEX OPERATORS MANUAL FOR USE WITH SOFTWARE 5.6 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 CUSTOMER-PROVIDED PHOTOGRAPHS VERIFY CLOTS IN THE CENTRIFUGE BOWL. THE ROOT CAUSE FOR THE CLOTTING OBSERVED HAS DETERMINED TO BE USE ERROR BECAUSE THE CUSTOMER USED HEPARIN WITH A CONCENTRATION OF 100 U/ML INSTEAD OF 25,000 U/ML. NO FURTHER ACTION IS REQUIRED AT THIS TIME; THIS INVESTIGATION IS NOW COMPLETE. (B)(4), (B)(6) 2026.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED THERAKOS TO REPORT CLOTS OBSERVED IN THE RETURN LINE WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED ALARM #16: COLLECT PRESSURE AND ALARM #17: RETURN PRESSURE ALARMS AND OBSERVED BLOOD CLOTTING IN THE RETURN LINE WHEN APPROXIMATELY 499 ML OF WHOLE BLOOD HAD BEEN PROCESSED. CLOTS WERE ALSO FOUND IN THE PATIENT LINE, CENTRIFUGE BOWL, AND BLOOD FILTER. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER HAD USED THE WRONG ANTICOAGULANT (HEPARIN) CONCENTRATION - 100 U/ML INSTEAD OF 25000 U/ML. THE CUSTOMER RETURNED PHOTOS FOR EVALUATION. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58700 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS DEVELOPMENT LIMITED NA P234 00705030000005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female