BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEXELL THERAPEUTICS TEDEX 300I

    MDR report key: 274189 · Received April 18, 2000

    Report

    Report Number
    MW1018684
    Event Type
    Death
    Date Received
    April 18, 2000
    Date of Event
    April 10, 2000
    Report Date
    April 17, 2000
    Manufacturer
    NEXELL THERAPEUTICS, INC.
    Product Code
    GKT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS READMITTED TO INPATIENT CARE DAY 18 POST STEM-CELL TRANSPLANT. C/O FEVER, COUGH, DIARRHEA. FOUND TO HAVE CYTOMEGALOVIRUS ENTERITIS. STARTED AGGRESSIVE TREATMENT BUT PRESENTED W/PNEUMONIA AND CYTOMEGALOVIRUS ENTERITIS. LYMPH NODE BIOPSY PERFORMED WHICH WAS POSITIVE FOR EPSTEIN-BARR VIRUS RELATED LYMPHOMA. PT WAS TRANSFERRED TO ICU, INTUBATED, AND SINGLE DOSE RITALIN GIVEN. PT CONTINUED TO DETERIORATE, DEVELOPED PROFOUND HYPOTENSION AND WENT INTO COMPLETE RENAL FAILURE. RPTR SUSPECTS THE PROFOUND IMMUNOSUPPRESSED STATE FROM THE CD34 SELECTION AND RABBIT ATG WAS LIKELY RESPONSIBLE FOR THE REACTIVATION OF CMV AND THE SUBSEQUENT DEVELOPMENT OF EBV-ASSOCIATED LYMPHOMA. TWO OF THE ONLY TWO PTS WHO RECEIVED THE FULL COURSE OF RABBIT ATG HAVE DEVELOPED AN AGGRESSIVE FORM OF EBV LYMPHOMA. OF 28 PTS WHO RECEIVED HORSE ATG, NONE HAVE DEVELOPED ANY LIFE THREATENING COMPLICATIONS RELATED TO THE IMMUNOSUPPRESSED STATE. RPTR IS AMENDING THE PROTOCOL TO ALLOW ONLY HORSE ATG AND IF PTS ARE SENSITIVE TO THE AGENT, THEY WILL NOT RECEIVE EITHER FORM OF THE AGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXELL THERAPEUTICS TEDEX 300I CELL SEPARATION GKT NEXELL THERAPEUTICS, INC. 300I KIT# 2693T002AA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death 1. TBI 2/12 - 2/13/2000| 3. PBSC INFUSION 2/17/2000| 2. CYCLOPHOSPHAMIDE 2/14 - 2/15/2000