BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX

    MDR report key: 3873899 · Received May 29, 2014

    Report

    Report Number
    3873899
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    February 24, 2014
    Report Date
    May 29, 2014
    Manufacturer
    THERAKOS
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DURING ECP TREATMENT HAD #45 - RED CELL PUMP ALARMS AT 335ML, 1307ML & 1342ML WBP. DECREASED COLLECT RATE TO 25ML/MIN AND RETURN RATE TO 30ML/MIN. AFTER 3RD ALARM - LOWERED WBP TO 1307ML TO INITIATE EARLY BUFFY COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316803 CELLEX KIT, SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL LNR THERAKOS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR