BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX SYSTEM

    MDR report key: 6185001 · Received December 19, 2016

    Report

    Report Number
    6185001
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 18, 2016
    Report Date
    November 28, 2016
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CELLEX SYSTEM WOULD NOT PRIME. THERAKOS SUPPORT CALLED. THE DEVICE COULD NOT BE FIXED WITH TROUBLESHOOTING OVER THE TELEPHONE. THERAKOS SENT TECHNICIAN TO REPAIR EQUIPMENT. THERAKOS TECHNICIAN REPAIRED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837606 CELLEX SYSTEM SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL LNR THERAKOS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR