BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4326980 · Received December 11, 2014

    Report

    Report Number
    2523595-2014-00321
    Event Type
    Death
    Date Received
    December 11, 2014
    Date of Event
    October 3, 2014
    Report Date
    December 8, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER WAS REPORTED, THEREFORE, NO BATCH RECORD REVIEW WAS PERFORMED. THERE WERE NO TRENDS DETECTED FOR COMPLAINT CATEGORIES, DEATH OR MULTI-ORGAN FAILURE. (B)(6) YEAR OLD MALE WITH GRADE 4 ACUTE GVHD OF MDS DIED OF MULTI-ORGAN FAILURE. PT ONLY HAD 8 ECP TREATMENTS. THIS CASE IS SERIOUS AND NOT RELATED TO ECP THERAPY. THERAKOS IS REPORTING THIS OUT OF AN ABUNDANCE OF CAUTION. KIT UNIQUE IDENTIFIER (UDI) #: .

    Description of Event or Problem · 1

    EVENT REPORTED IN A LITERATURE ARTICLE: JOURNAL OF PEDIATRIC HEMATOLOGY/ONCOLOGY 2014;00:000-000. ACCEPTED FOR PUBLICATION 10/03/2014. "SAFETY AND OUTCOMES OF EXTRACORPOREAL PHOTOPHERESIS WITH THE THERAKOS CELLEX SYSTEM FOR GRAFT-VERSUS-HOST-DISEASE IN PEDIATRIC PATIENTS." (B)(6) YEAR OLD BOY, ONE OF FOUR PATIENTS (ALL FOUR WITH LIVER INVOLVEMENT) IN A RETROSPECTIVE REVIEW OF TWELVE PEDIATRIC PATIENTS THAT FAILED TO RESPOND TO THE TREATMENT DIED OF MULTI-ORGAN FAILURE, NO STEROID TAPERING. HSCT INDICATION: MDS, MYELODYSPLASTIC SYNDROME. DONOR: (B)(6), MATCHED UNRELATED DONOR (B)(6). STEM CELL: PBSC (PERIPHERAL BLOOD STEM CELL). ONSET OF GVHD (WK): 1. GVHD TREATMENT (PRE-ECP): CSA (CYCLOSPORINE), TACR (TACROLIMUS), MMF (MYCOPHENOLATE MOFETIL), MP (METHYLPREDNISOLONE), ATG (ANTITHYMOCYTE GLOBULIN). INTERNAL BETWEEN ONSET OF GVHD AND ECP (WK): 2. GVHD TYPE: ACUTE (BIOPSY PROVEN). AFFECTED ORGANS (STAGE IN AGVHD, SCORE IN CGVHD): SKIN (4), GIS GASTROINTESTINAL (3), LIVER (2). DEGREE OF GVHD: GRADE 4 ACUTE GVHD. IMPROVEMENT: ACUTE GRADE 4 TO 3. ECP PROCEDURES: 8. GVHD TREATMENT DURING ECP: TACR, MMF, MP. BEGINNING OF IMPROVEMENT (IF ANY), (NUMBER OF PROCEDURES): 4. SURVIVAL: EXPIRED. CURRENT STATUS: DIED OF MULTI-ORGAN FAILURE, NO STEROID TAPERING. DATE OF DEATH WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804328 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Death