BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM

    MDR report key: 23490601 · Received November 6, 2025

    Report

    Report Number
    3036773437-2025-00009
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 6, 2025
    Manufacturer
    THERAKOS DEVELOPMENT LIMITED
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS AN MDR AS THE PATIENT'S STROKE IS CONSIDERED LIFE-THREATENING AND ALSO 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. FROM THE INSTRUMENT PERSPECTIVE, THERE WAS NO KNOWN INSTRUMENT MALFUNCTION AND NO SERVICE WAS REQUESTED BY THE CUSTOMER FOR THIS ADVERSE EVENT. NO PRODUCT WAS RETURNED; THEREFORE, A DEVICE SERVICE HISTORY REVIEW WAS PERFORMED. THE INSTRUMENT HAS BEEN LOCATED AT THE CUSTOMER'S SITE SINCE (B)(6) 2012. AS PART OF THE REVIEW, IT WAS DETERMINED THAT THE INSTRUMENT'S LAST SERVICE PRIOR TO THE EVENT WAS ON 11-APR-2025. DURING THIS SERVICE THE SYSTEM CHECKOUT PROCEDURE WAS SUCCESSFULLY COMPLETED INDICATING THAT THE INSTRUMENT HAD PASSED ALL TESTS, MET ALL SPECIFICATIONS, AND WAS OPERATIONAL. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, BLURRED VISION, HEADACHE, HYPERTENSION, AND STROKE / CEREBROVASCULAR ACCIDENT. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. THE ROOT CAUSE FOR THE PATIENT'S BLURRED VISION, HEADACHE AND HYPERTENSION IS MOST LIKELY DUE TO THE PATIENT'S ISCHEMIC STROKE PER THE HEALTH CARE PROFESSIONAL. THE ROOT CAUSE FOR THE STROKE / CEREBROVASCULAR ACCIDENT COULD NOT BE DETERMINED AS THERE WAS NO REPORTED INSTRUMENT ISSUE, NO PRODUCT WAS RETURNED FOR INVESTIGATION, AND NO INSTRUMENT SERVICE WAS 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. ADVERSE EVENT TERMS: BLURRED VISION, HEADACHE, HYPERTENSION, STROKE / CEREBROVASCULAR ACCIDENT. (B)(4), (B)(6) 2025.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED AN STROKE FOLLOWING AN ECP TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THE PATIENT UNDERWENT ECP TREATMENT PROCEDURES ON (B)(6) 2025. THE CUSTOMER STATED THAT AFTER THE ECP TREATMENT WAS COMPLETED AND THE PATIENT WAS DISCONNECTED, THE PATIENT BEGAN TO COMPLAIN OF A HEADACHE AND BLURRED VISION. THE CUSTOMER STATED THE PATIENT EXPERIENCED A LOSS OF VISION AND HYPERTENSION. THE CUSTOMER STATED THAT THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT ON (B)(6) 2025 AND AN ISCHEMIC STROKE WAS DIAGNOSED THROUGH A CT SCAN. THE CUSTOMER STATED THAT THE PATIENT RECEIVED TENECTEPLASE TREATMENT AND ADMITTED TO THE HOSPITAL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL; HOWEVER, IT IS UNKNOWN WHEN THE PATIENT WAS DISCHARGED AND IF THEY REQUIRED ANY ADDITIONAL MEDICATION OF REHABILITATION. THE PATIENT WILL BE CONTINUING WITH ECP TREATMENTS. IT IS UNKNOWN IF THE PATIENTS ISCHEMIC STROKE WAS RELATED TO ECP. NO PRODUCT WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907020 CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM LNR THERAKOS DEVELOPMENT LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention| H| L