BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM

    MDR report key: 25046259 · Received April 30, 2026

    Report

    Report Number
    3036773437-2026-00035
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 30, 2026
    Manufacturer
    THERAKOS DEVELOPMENT LIMITED
    Product Code
    LNR
    UDI-DI
    10705030100009
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE DUE TO THE MEDICAL INTERVENTION THAT WAS PROVIDED TO THE PATIENT. SINCE THIS EVENT IS ASSOCIATED WITH THE TREATMENT, THIS MDR WILL BE AGAINST THE INSTRUMENT. THERE HAS BEEN NO KNOWN INSTRUMENT MALFUNCTION, AND NO SERVICE HAS BEEN REQUESTED BY THE CUSTOMER. NO PRODUCT HAS BEEN RETURNED. A DEVICE SERVICE HISTORY REVIEW HAS BEEN PERFORMED; THE INSTRUMENT HAS BEEN LOCATED AT THE CUSTOMER'S SITE SINCE 20/JUL/2020, AND THE INSTRUMENT HAS HAD NO DOCUMENTED PRIOR SERVICES. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, ALARM #10: BUFFY VOLUME EXCEEDED. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. THE ROOT CAUSE 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. THERE IS NO MENTION OF A CASUAL RELATIONSHIP BETWEEN THE PATIENT EVENT(S) AND THE ECP TREATMENT. THIS INVESTIGATION IS BASED ON CURRENTLY AVAILABLE INFORMATION. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS INVESTIGATION IS NOW COMPLETE. PQC-002210. JM 30/APR/2026.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED THERAKOS TO REPORT AN ALARM #10: BUFFY VOLUME EXCEEDED WAS RECEIVED DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THERE WERE NO ISSUES OBSERVED DURING THE TREATMENT. THE CUSTOMER REPORTED THE TREATMENT WAS COMPLETED, HOWEVER, AN UNPLANNED BLOOD TRANSFUSION WAS ADMINSTERED TO THE PATIENT AFTER TREATMENT. ALTHOUGH REQUESTED, NO REASONING BEHIND THE TRANSFUSION HAS BEEN PROVIDED. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE AND IN GOOD CONDITIONS BEFORE THE TRANSFUSION. NO PRODUCT HAS BEEN RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59889 CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM LNR THERAKOS DEVELOPMENT LIMITED 10705030100009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention