BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS PROCEDURAL KIT

    MDR report key: 24924908 · Received April 20, 2026

    Report

    Report Number
    24924908
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    February 13, 2026
    Report Date
    April 6, 2026
    Manufacturer
    THERAKOS LLC
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE SETTING UP THE CELLEX MACHINE, THE BOWL IN THE KIT WAS NOTED TO BE TOO TIGHT AND TOO DIFFICULT TO LOCK WHEN INSTALLING IT INTO HOLDER. THE DECISION WAS MADE TO DISCARD THE KIT. THIS IS A THE SAME ISSUE THAT WAS INVOLVED IN THE RECALL IN 2025. MANUFACTURER RESPONSE FOR PHOTOPHERESIS SYSTEM PROCEDURAL KIT, THERAKOS CELLECX PHOTOPHERESIS SYSTEM PROCEDURAL KIT (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458831 THERAKOS CELLEX PHOTOPHERESIS PROCEDURAL KIT SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL LNR THERAKOS LLC P319/486

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other