BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM

    MDR report key: 2121051 · Received June 9, 2011

    Report

    Report Number
    2523595-2011-00018
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 9, 2011
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORTS OF A DEVICE MALFUNCTION HAVE BEEN REC'D TO DATE. A LOT FILE REVIEW WAS PERFORMED ON LOT Z701. THE LOT WAS MANUFACTURED IN 01/2011, EXPIRATION DATE 01/01/16. LOT Z701 MET QA RELEASED REQUIREMENTS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THERAKOS REC'D A REPORT OF A PT WHO EXPERIENCED A FEVER DURING AN ECP PROCEDURE ON A THERAKOS XTS INSTRUMENT. THE PT'S TEMPERATURE WAS 38.2 C AT BEGINNING OF THE RETURN PHASE DURING 2ND CYCLE. TREATMENT WSA STOPPED AND CLINICIANS EXAMINED THE PT. AFTER 30 MINUTES, PT HAD NO FEVER AND TREATMENT WAS RESUMED. THE PHYSICIAN ADMINISTERED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM XTS ECP SYSTEM LNR THERAKOS Z701

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other| R