BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS ® CELLEX ® PHOTOPHERESIS

    MDR report key: 24518276 · Received March 5, 2026

    Report

    Report Number
    24518276
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    January 16, 2026
    Report Date
    March 2, 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

    S [SITUATION] MULTIPLE THERAKOS PHOTOPHERESIS KITS DEFECTIVE. B [BACKGROUND] WHILE SETTING UP PHOTOPHERESIS KITS LATHAM BOWL DID NOT FIT INTO MACHINE. A [ASSESSMENT] NURSES WERE TRYING TO FIT BOWL IN, BUT COMPANY SUGGESTED SENDING KIT BACK AS FORCING IT MAY LEAD TO BREAKAGE DURING PROCEDURE. R [RECOMMENDATION] CLINICAL SITE CALLED THERAKOS REP TO REPORT THE ISSUE AND ASKED THAT KITS BE SENT BACK TO COMPANY. THIS PRODUCT HAS BEEN RECALLED WITHIN THE LAST TWO YEARS FOR THE SAME ISSUE. MANUFACTURER RESPONSE FOR PHOTOPHERESIS KIT, THERAKOS ® CELLEX ® PHOTOPHERESIS (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577918 THERAKOS ® CELLEX ® PHOTOPHERESIS SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL LNR THERAKOS LLC 40959 P313 AND P750

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other