BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS PHOTOPHERESIS

    MDR report key: 3072818 · Received April 17, 2013

    Report

    Report Number
    MW5029857
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 17, 2013
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS IN CLINIC RECEIVING PHOTOPHERESIS THERAPY WHEN STAFF NOTED CLOTTING OF THE PT'S BLOOD IN SEVERAL AREAS IN THE MACHINE. THE STAFF NOTED THE SALINE AND HEPARINIZED SALINE LINES WERE PRE-ATTACHED IN THE INCORRECT SPOT ON THE FLUID LOGIC MODULE. THE PT HAD A BLOOD LOSS OF ABOUT 400-500 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165557 THERAKOS PHOTOPHERESIS PHOTOPHERESIS KIT LNR THERAKOS, INC XTS 125 ML KIT A758

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention