BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UVAR XTS PHOTOPHERESIS SYSTEM

    MDR report key: 651767 · Received December 6, 2005

    Report

    Report Number
    2523595-2005-00004
    Event Type
    Malfunction
    Date Received
    December 6, 2005
    Date of Event
    August 26, 2005
    Report Date
    November 30, 2005
    Manufacturer
    THERAKOS
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SUBJECT WAS ENROLLED IN THE RHEUMATOID ARTHRITIS STUDY (A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE BLIND, "SHAM" PHERESIS-CONTROLLED, STUDY OF EXTRACORPOREAL PHOTOIMMUNE THERAPY (ECP) WITH UVADEX FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN PATIENTS WHO HAVE AN INADEQUATE RESPONSE TO DISEASE-MODIFYING ANTIRHEUMATIC DRUGS AND BIOLOGICAL AGENTS.) THE PATIENT HAD A MEDICAL HISTORY OF ANEMIA. SUBJECT RECEIVED ECP THERAPY FOR 38 DAYS. ON EVENT DATE SUBJECT EXPERIENCED A 250CC BLOOD LOSS DURING ECP THERAPY. OPERATOR NOTICED PLASMA LEAKING FROM BOWL, POSSIBLY FROM SEAL AREA, DURING CYCLE 1 BUFFY COLLECTION. AS A PRECAUTION, TREATMENT WAS DISCONTINUED AND BLOOD WAS NOT RETURNED TO THE PATIENT. NO BLOOD LEAK OR OTHER ALARMS OCCURRED. THE CENTRIFUGE BOWL, THE CELL SEPARATOR PORTION OF THE XT-125 PROCEDURAL KIT, WAS RETURNED TO THERAKOS FOR EVALUATION. A ONE HALF INCH CRACK WAS FOUND IN THE STEM OF THE UPPER BOWL ASSEMBLY HEADER SHIELD. THE BOWL WAS SANITIZED WITH 10% BLEACH SOLUTION AND SENT TO HARMONETICS CORPORATION, MANUFACTURER OF THE CENTRIFUGE BOWL. HAEMONETICS CONFIRMED THE BOWL LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UVAR XTS PHOTOPHERESIS SYSTEM EXTRACORPOREAL PHOTOPHERESIS SYSTEM LNR THERAKOS XT-125 S738

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R