BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PROCEDURAL KIT

    MDR report key: 4275267 · Received October 30, 2014

    Report

    Report Number
    4275267
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    July 18, 2014
    Report Date
    October 30, 2014
    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

    INITIALLY STARTED ECP TREATMENT ON CELLEX INSTRUMENT. EXPERIENCED MULTIPLE AIR IN LINE ALARMS -- FOLLOWED CORRECTION PROMPTS/APPLIED BP CUFF AND HEAT AND CONSULTED THERAKOS BUT UNABLE TO RESOLVE ALARMS. TREATMENT WAS ENDED AND ALL WHOLE BLOOD PROCESSED WAS RETURNED TO THE PATIENT. PATIENT WAS SUCCESSFULLY TREATED ON A DIFFERENT CELLEX INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694664 CELLEX PROCEDURAL KIT SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL LNR THERAKOS, INC. * C320/262

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR NOT APPLICABLE.