BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM

    MDR report key: 24915081 · Received April 17, 2026

    Report

    Report Number
    3036773437-2026-00033
    Event Type
    Injury
    Date Received
    April 17, 2026
    Report Date
    April 17, 2026
    Manufacturer
    THERAKOS DEVELOPMENT LIMITED
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS A MDR AS THE INCIDENT WAS CONSIDERED LIFE THREATENING DUE TO THE PULMONARY EMBOLISM REPORTED. SINCE THIS EVENT IS ASSOCIATED WITH THE TREATMENT, THIS MDR WILL BE AGAINST THE INSTRUMENT. THERE WAS NO SERIAL NUMBER PROVIDED AND NO KNOWN INSTRUMENT MALFUNCTION, AND NO SERVICE HAS BEEN REQUESTED BY THE CUSTOMER. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, PULMONARY EMBOLISM. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. PER THE CELLEX OPERATOR'S MANUAL SECTION 2-9 ON ANTICOAGULANT: "THERE ARE TWO DIFFERENT ANTICOAGULANTS THAT MAY BE USED WITH THE THERAKOS¿ CELLEX¿ PHOTOPHERESIS SYSTEM. SELECT ANTICOAGULANT AT START OF THE TREATMENT. 1. HEPARINIZED SALINE SOLUTION OR 2. ANTICOAGULANT CITRATE DEXTROSE SOLUTION, SOLUTION A, (ACD-A)." THERE IS NO RECOMMENDED MIX OF HEPARIN AND ACD-A IN THE CELLEX OPERATOR'S MANUAL. IN ADDITION, SECTION 2-9 ON ANTICOAGULANT STATES: "CAUTION: HEPARIN: INDIVIDUAL PATIENTS MAY REQUIRE A HEPARIN DOSAGE THAT VARIES FROM THE RECOMMENDED DOSE TO PREVENT POST-TREATMENT BLEEDING OR CLOTTING DURING A TREATMENT. THE CLINICIAN SHOULD REVIEW THE PATIENT'S MEDICAL CONDITION, MEDICATIONS AND PLATELET COUNT AT THE TIME OF TREATMENT AND USE CLINICAL JUDGMENT TO ESTABLISH THE OPTIMAL HEPARIN DOSAGE FOR EACH PATIENT. SPECIAL ATTENTION TO ADEQUATE ANTICOAGULATION IS ADVISED WHEN TREATING PATIENTS WITH GVHD, A CONDITION ASSOCIATED WITH AN INCREASED RISK OF THROMBOEMBOLIC EVENTS. THROMBOEMBOLIC EVENTS (INCLUDING PULMONARY EMBOLISM AND DEEP VEIN THROMBOSIS) HAVE BEEN REPORTED WITH THE USE OF THE THERAKOS¿ CELLEX¿ PHOTOPHERESIS SYSTEM IN THE TREATMENT OF GVHD." THE ROOT CAUSE FOR THE PATIENT'S PULMONARY EMBOLISM COULD NOT BE DETERMINED AS THERE WAS NO REPORTED INSTRUMENT ISSUE, NO RETURNED PRODUCT FOR INVESTIGATION, AND NO INSTRUMENT SERVICE REQUESTED BY THE CUSTOMER OR PERFORMED BY THERAKOS AS A RESULT OF THIS INCIDENT. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS INVESTIGATION IS NOW COMPLETE. PQC-001793 JM 17/APR/2026.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED THERAKOS REQUESTING INFORMATION REGARDING MIXING HEPARIN AND ACD-A ANTICOAGULANT FOR A CELLEX EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED IN THE PAST A PATIENT EXPERIENCED A PULMONARY EMBOLISM WHEN MIXED ANTICOAGULANT WAS USED DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THE INCIDENT OCCURRED YEARS AGO. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING THE PATIENT OR DETAILS OF THE TREATMENT. NO PRODUCT WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398760 CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM LNR THERAKOS DEVELOPMENT LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening