BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4326986 · Received December 11, 2014

    Report

    Report Number
    2523595-2014-00322
    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. A (B)(6)MALE WITH GRADE 3 ACUTE GVHD AND SEVERE CGVHD OF ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) DIED OF CATHETER INFECTIONS, STEROIDS WERE TAPERED DUE TO STEROID SIDE EFFECTS. PATIENT ONLY HAD 8 HCP TREATMENTS. THIS CASE IS SERIOUS AND NOT RELATED TO ECP THERAPY. THERAKOS IS REPORTING THAT OUT OF ABUNDANCE OF CAUTION. KIT UNIQUE IDENTIFIER (UDI)#: (B)(4).

    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." A (B)(6), ONE OF FOUR PATIENTS (ALL FOUR WITH LIVER INVOLVEMENT) IN A RETROSPECTIVE REVIEW OF TWELVE PEDIATRIC PATIENTS THAT FAILED TO RESPOND TO THE TREATMENT AND DIED OF CATHETER INFECTION, STEROID TAPERED DUE TO STEROID SIDE EFFECTS. HSCT INDICATION: ALL, ACUTE LYMPHOBLASTIC LEUKEMIA DONOR: MUD, MATCHED UNRELATED DONOR (9/10). STEM CELL: BM, BONE MARROW. ONSET OF GVHD (WK): GVHD TREATMENT (PRE-ECP): TACR (TACROLIMUS), MMF (MYCOPHENOLATE MOFETIL), MP (METHYLPREDNISOLINE). INTERVAL BETWEEN ONSET OF GVHD AND ECP (WK): 20 GVHD TYPE: OVERLAP (BIOPSY PROVEN). AFFECTED ORGANS (STAGE IN AGVHD, SCORE IN CGVHD): CHRONIC SKIN (3), ACUTE SKIN (1), ACUTE GIS GASTRIINTESTINAL (2), LIVER (2). DEGREE OF GVHD: GRADE 3 ACUTE GVHD, SEVERE CHRONIC GVHD. IMPROVEMENT: ACUTE: NO IMPROVEMENT, CHRONIC: SEVERE TO MODERATE. ECP PROCEDURES: GVHD TREATMENT DURING ECP: TACR, MMF, MP. BEGINNING OF IMPROVEMENT (IF ANY) (NUMBER OF PROCEDURES): SURVIVAL: EXPIRED. CURRENT STATUS: DIED OF CATHETER INFECTIONS, STEROID TAPERED DUE TO STEROID SIDE EFFECTS. DATE OF DEATH WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804329 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Death