BEUDAMED
    FDA Adverse Event Death Summary report: N

    UVAR XTS PHOTOPHERESIS SYSTEM

    MDR report key: 422807 · Received October 18, 2002

    Report

    Report Number
    2523595-2002-00003
    Event Type
    Death
    Date Received
    October 18, 2002
    Date of Event
    September 27, 2002
    Report Date
    October 16, 2002
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SERIOUSLY ILL GVHD PT WAS RECEIVING THEIR 26TH PHOTOPHERESIS THERAPY. ALL PRIOR THERAPIES WERE UNEVENTFUL. IN 2002 THE PT'S THERAPY WITH THE UVAR XTS PHOTOPHERESIS SYSTEM WAS AT THE END OF CYCLE 2 PHASE, READY FOR PLASMA AND PACKED RBC'S TO BE RETURNED TO THE PT. THE NURSE NOTICED IN THE PHOTOACTIVATION CIRCUIT WHERE THE BUFFY COAT AND SOME PLASMA HAD BEEN COLLECTED DURING CYCLE 1 AND 2, WHITE CLUMPS OR PARTICULATES, POSSIBLY FAT (PT WAS LIPEMIC 1140 MG/DL). THE PHYSICIAN IN THE PHERESIS UNIT ADDED A STANDARD TRANSFUSION FILTER BETWEEN THE UVAR XTS PHOTOPHERESIS PT LINE ACCESS AND THE PT. THIS WAS DONE TO COLLECT ANY POSSIBLE FAT PARTICULATE THAT MAY BE IN THE TUBING. THIS WAS MOST LIKELY NOT NECESSARY BECAUSE THE UVAR XTS PROCEDURAL KIT HAS A RETURN FILTER. THE STANDARD TRANSFUSION FILTER ADDED BY THE CENTER WAS NOT RECOMMENDED BY THE CO'S OPERATOR'S MANUAL AND IS DOWN STREAM OF THE CO'S AIR DETECTORS. THE Y-TYPE BLOOD SET, -OL 122 INCH MADE BY ABBOTT, WAS MODIFIED PRIOR TO INSTALLING. UP TO THIS POINT, THE THERAPY WAS UNEVENTFUL. IMMEDIATELY UPON RETURNING THE CELLS FROM CYCLE 2, THE PT BEGAN EXPERIENCING SHORTNESS OF BREATH. THE THERAPY WAS ENDED WITHOUT ADDITION OF UVADEX OR PHOTOACTIVATION OF COLLECTED BUFFY COAT CELLS. THE COLLECTED BUFFY COAT CELLS WERE NOT RETURNED TO THE PT BASED ON SYMPTOMS, A PULMONARY EMBOLISM WAS SUSPECTED. A VQ SCAN WAS PERFORMED BUT THE VQ SCAN INDICATED LOW PROBABILITY OF PULMONARY EMBOLISM. THE PT WAS PLACED IN ICU AND CONTINUED TO DETERIORATE OVER THE NEXT THREE DAYS AND DIED. THE PT'S FAMILY MEMBERS REFUSED AN AUTOPSY. THE UVAR XTS PROCEDURAL KIT, XT125 LOT #Q711, WAS DISCARDED ALONG WITH THE DATA KEY. THE 120 MICRON TRANSFUSION FILTER, INSTALLED BY THE HOSPITAL, WAS REPORTEDLY DISCARDED BY THE HOSPITAL AND NO CLOTS, FAT GLOBULES OR PARTICULATE WAS FOUND. THE UVAR XTS PHOTOPHERESIS INSTRUMENT WAS EVALUATED ON-SITE BY THERAKOS AND THE HOSPITAL IN 2002 AND NO PROBLEMS WITH THE INSTRUMENT WERE FOUND. THE INSTRUMENT FUNCTIONED DURING ALL TESTS WITHOUT ANY FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UVAR XTS PHOTOPHERESIS SYSTEM UVAR XTS PHOTOPHERESIS SYSTEM LNR THERAKOS, INC. VVAR XTS PHOTOPHERESIS SYSTEM Q711 (PROCEDURAL KIT)

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Death