BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM

    MDR report key: 2251247 · Received September 12, 2011

    Report

    Report Number
    2523595-2011-00019
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 27, 2011
    Report Date
    September 12, 2011
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT # Z726. (B)(4). THE SITE INDICATED THAT THE CAUSE MIGHT POSSIBLY LIE IN THE PROGRESSION OF REJECTION. NO REPORTS OF A DEVICE MALFUNCTION HAVE BEEN RECEIVED TO DATE. A LOT FILE REVIEW WAS PERFORMED ON LOT Z717 AND Z726 WHICH INCLUDED A REVIEW OF THE (B)(4) STERILIZATION PROCESS. NO NON-CONFORMANCES WERE FOUND AND THE KIT LOTS MET QA RELEASE REQUIREMENTS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THERAKOS RECEIVED A REPORT OF A PT WHO EXPERIENCED SHORTNESS OF BREATH AFTER ECP THERAPY ON (B)(6) 2011. THE EPISODES OF SHORTNESS OF BREATH OCCURRED ON THREE SUBSEQUENT DAYS, EACH DAY IN THE MORNING. THE EVENT WAS OBSERVED ON (B)(6) 2011, LASTED THROUGHOUT (B)(6) 2011, (B)(6) 2011, THEN IMPROVED. EPISODES WERE TREATED WITH PREDNISOLONE 50 MG AND THEOPHYLLIN 200 MG, WHICH RESULTED IN IMPROVEMENT. LUNG FUNCTION BEFORE AND AFTER ECP SHOWED REDOUBLING IN RESISTANCE AS WELL AS A DETERIORATION OF THE TRANSFER FACTOR. THE SITE INDICATED THAT THE CAUSE MIGHT POSSIBLY LIE IN THE PROGRESSION OF INJECTION. THE PT WAS ADMINISTERED OXYGEN AT THE TIME OF UNDERGOING ECP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM XTS ECP SYSTEM LNR THERAKOS Z717

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other