BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLEX 300I

    MDR report key: 5200424 · Received October 5, 2004

    Report

    Report Number
    5200424
    Event Type
    Injury
    Date Received
    October 5, 2004
    Date of Event
    September 27, 2004
    Report Date
    September 28, 2004
    Manufacturer
    BAXTER
    Product Code
    LKN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED LOW COUNTS AT 1 YR POST AUTOLOGOUS TRANSPLANTATION. COUNTS WERE WATCHED AND REPEATED AT 2 YRS. MARROW STUDIES WERE REQUESTED AT 2 YRS POST TRANSPLANT AND WERE NORMAL CELLULAR MARROW. HGB 10-11G; PLATELETS 120, NEUTROPHILS 1,500, 1,600 MARROW SHOWED NO INCREASE IN BLASTS WITH SOME MEGALOBLASTIC CHARGES. CYTOGENETIC STUDIES SHOWED A COMPLEX KARYOTYPE WITH T(4:17), T(6.9), -59 AND -7, (IPSS=1.0). CONSENSUS OF REVIEWING TEAM AFTER EVALUATING LABS AND MARROW STUDIES IS THAT PT HAS MYELODYSPLASTIC SYNDROME. PROBABLE CAUSE SUSPECTED TO BE TBI/CYCLOPHOSPHAMIDE/ATG REGIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLEX 300I CELL SEPARATION LKN BAXTER

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other