BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS CELLEX

    MDR report key: 3866723 · Received June 2, 2014

    Report

    Report Number
    MW5036503
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A PHOTOPHERESIS PROCEDURE, AT 21 MINUTES RUN-TIME, THE PRESSURE SYSTEM DONE, LOCATED ON THE CENTRIFUGE SYSTEM PRESSURE SENSOR, DISLODGED FROM THE SENSOR. THE INTERNAL MEMBRANE SEPARATED FROM THE PRESSURE DOME WHICH RESULTED IN A BLOOD LEAK AND SUBSEQUENT BLOOD LOSS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322116 THERAKOS CELLEX THERAKOS CELLEX PHOTOPHERESIS PROCEDURE KITS LNR THERAKOS, INC C316

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention