BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM

    MDR report key: 24735514 · Received March 30, 2026

    Report

    Report Number
    3036773437-2026-00028
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 (B)(6) 2023, AND NO PRIOR SERVICE EVENTS HAVE BEEN DOCUMENTED. NO TRENDS FOR MALAISET, TACHYCARDIA, HYPOXIA / HYPOXEMIA, HIGH BLOOD PRESSURE/ HYPERTENSION, LOW HEMATOCRIT, OR LOW HEMOGLOBIN HAVE BEEN OBSERVED. THE ROOT CAUSE FOR THE PATIENT'S ADVERSE EVENTS 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. IN ADDITION, THE PATIENT'S HEMATOCRIT WAS LOWER THAN RECOMMENDED WHEN STARTING THE TREATMENT. THE HEALTHCARE PROFESSIONAL STATED THEY BELIEVE THAT THE PATIENT'S UNDERLYING CONDITION(S) COULD HAVE CAUSED OR CONTRIBUTED TO THE MEDICAL INTERVENTION PERFORMED. THIS INVESTIGATION IS BASED ON CURRENTLY AVAILABLE INFORMATION. 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 A PATIENT FEELING "UNWELL" DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. HEMOGLOBIN HAD DROPPED TO 6.9, SO A BLOOD TRANSFUSION WAS ADMINISTERED. THE TREATMENT HAD BEGUN WITH HEMATOCRIT AT 22%. AT THE START OF ECP TREATMENT, SYSTOLIC BLOOD PRESSURE WAS 140MMHG, BUT DROPPED TO 90MMHG DURING TREATMENT. SPO2 WAS ALSO UNSTABLE, RANGING FROM AROUND 90 TO 97%, SO A SMALL AMOUNT OF OXYGEN WAS ADMINISTERED VIA THE NASAL PASSAGE. THE WHOLE BLOOD PROCESSING VOLUME WAS CHANGED TO 1250ML, AND TREATMENT CONTINUED, AFTER WHICH IT WAS TERMINATED. THE CUSTOMER HAS STATED THAT THEY BELIEVE THE PATIENT'S UNDERLYING CONDITION COULD HAVE CAUSED OR CONTRIBUTED TO THE INTERVENTIONS PERFORMED, HOWEVER, IT IS UNKNOWN IF THE ECP TREATMENT NECESSITATED THE OXYGEN DELIVERY. THE PATIENT REMAINS HOSPITALIZED. IT IS UNKNOWN IF THE PATIENT WILL BE CONTINUING ECP TREATMENT. NO PRODUCT WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796003 CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM LNR THERAKOS DEVELOPMENT LIMITED 10705030100009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H