BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEX PHOTOPHERESIS KIT

    MDR report key: 5515876 · Received March 17, 2016

    Report

    Report Number
    MW5061024
    Event Type
    Injury
    Date Received
    March 17, 2016
    Date of Event
    February 24, 2016
    Report Date
    March 17, 2016
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    UNABLE TO PRIME CELLEX PHOTOPHERESIS KIT LOT #D364, EXPIRY DATE 10/01/2017 DUE TO MULTIPLE REOCCURRENCES OF ALARM "PRIME 1". TWO KITS WERE USED WITHOUT SUCCESS. THE MFR WAS NOTIFIED OF THE EVENT AND THE KITS WERE SAVED AND SENT FOR EVALUATION. REPORT PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163307 CELLEX PHOTOPHERESIS KIT CELLEX PHOTOPHERESIS KIT LNR THERAKOS INC. D364

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention