BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, PHOTOPHERESIS, PROCEDURAL

    MDR report key: 2494652 · Received February 28, 2012

    Report

    Report Number
    2494652
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Date of Event
    January 19, 2012
    Report Date
    February 24, 2012
    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

    WE HAD CELLEX ALARMS NUMBER 25 FOUR TIMES. A FLUID LEAK WAS NOTED DURING THE PRIME. WE REPRIMED ANOTHER CELLEX KIT AND NOTIFIED THERAKOS. THE KIT WILL BE SHIPPED TO THERAKOS FOR FURTHER INSPECTION. WE ARE AWAITING A RESPONSE FROM THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT, PHOTOPHERESIS, PROCEDURAL EXTRACORPOREAL PHOTOPHERESIS (ECP) KIT LNR THERAKOS, INC. * Z321

    Patients

    Seq Age Sex Outcome Treatment
    1 *