BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTOPHERESIS, ECP

    MDR report key: 2291669 · Received October 1, 2011

    Report

    Report Number
    2291669
    Event Type
    Malfunction
    Date Received
    October 1, 2011
    Date of Event
    September 13, 2011
    Report Date
    October 1, 2011
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS THE PRIMING KIT ON THE CELL EX FOR THE MORNING EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE COLLECT PUMP TUBING SEGMENT WAS NOTED TO BE TOO LONG. THERAKOS WAS CONTACTED AND THE KIT ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOTOPHERESIS, ECP ECP (PHOTOPHERESIS) LNR THERAKOS, INC. * Z391

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR OTHER