BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELLEX

    MDR report key: 1586041 · Received January 21, 2010

    Report

    Report Number
    2523595-2010-00002
    Event Type
    Death
    Date Received
    January 21, 2010
    Date of Event
    December 23, 2009
    Report Date
    January 22, 2010
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNLIKELY THE ECP TREATMENT CONTRIBUTED TO THE DEATH AS THE UNDERLYING DIAGNOSIS OF HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS HAS AN EXTREMELY POOR PROGNOSIS AND THREE WEEKS LAPSED, SINCE THE LAST ECP TREATMENT AND THE TERMINAL EVENT. A THERAKOS FIELD ENGINEER VISITED THE SITE AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND TO FUNCTION AS INTENDED.

    Description of Event or Problem · 1

    THE PT WAS BEING TREATED FOR GUT GVHD. HER LAST TREATMENT WAS IN 2009. HER DEATH WAS ATTRIBUTED TO A 'RECURRENCE OF HER MALIGNANCY'. UNDERLYING DIAGNOSIS WAS HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS. THE ATTENDING PHYSICIAN REPORTED THE DEATH APPEARED TO BE A RESULT OF THE UNDERLYING CONDITION OF THE PT, AND NOT THE TREATMENT NOR THE ADMINISTRATION OF METHOXSALEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELLEX CELLEX LNR THERAKOS CELLEX

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death