BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS PROCEDURAL KIT

    MDR report key: 1941630 · Received December 20, 2010

    Report

    Report Number
    1941630
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 18, 2010
    Report Date
    December 20, 2010
    Manufacturer
    THERAKOS CELLEX
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    AIR IN THE TREATMENT BAG LINE WAS NOTICED AFTER THE TREATMENT BAG WAS COMPLETELY EMPTY. WE WERE UNABLE TO CLEAR THE LINE OR TO TRICK THE MACHINE IN ORDER TO RETURN THE BLOOD FROM THE RETURN BAG TO THE PT. THE TREATMENT WAS ABORTED AND A MANUAL RETURN OF THE PT'S BLOOD WAS PERFORMED. AFTERWARDS, THE PT WAS TREATED ON THE XTS INSTRUMENT WITHOUT AN INCIDENT. WE ARE CURRENTLY AWAITING A RESPONSE FROM THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELLEX PHOTOPHERESIS PROCEDURAL KIT CELLEX INSTRUMENT DISPOSABLE KIT/ PHOTOPHERESIS PROCEDURAL K LNR THERAKOS CELLEX * Y302

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR