BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX

    MDR report key: 4272861 · Received October 20, 2014

    Report

    Report Number
    4272861
    Event Type
    Malfunction
    Date Received
    October 20, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 20, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    EXTRACOPOREAL PHOTOCHEMOTHERAPY DEVICE TREATMENT STARTED ON CELLEX AT 11. CHECKED ON PATIENT AT 1110, NO PROBLEMS WITH THE MACHINE. WHEN WENT BACK IN TO CHECK ON PATIENT, FOUND THAT THE SENSOR WAS NO LONGER ON AND BLOOD WAS LEAKING OUT OF RUPTURED MEMBRANE OF TUBING. IMMEDIATELY CLAMPED PATIENT'S LINE AND PAUSED CELLEX. NO ALARMS WENT OFF. FLUSHED PATIENT'S LINE TO MAINTAIN PATENCY. CONTAINED BLOOD SPILL. TOOK MACHINE OUT OF SERVICE. MANUFACTURER RESPONSE FOR EXTRACORPOREAL PHOTOCHEMOTHERAPY DEVICE, THERAKOS CELLEX (PER SITE REPORTER).======================REPORTER STATED PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665508 CELLEX SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL LNR THERAKOS, INC. * C338

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR