BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS PHOTOPHERESIS KIT

    MDR report key: 2809293 · Received September 23, 2012

    Report

    Report Number
    2809293
    Event Type
    Malfunction
    Date Received
    September 23, 2012
    Date of Event
    August 27, 2012
    Report Date
    September 20, 2012
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CELLEX MACHINE ATTACHED TO PATIENT. CELLEX TREATMENT STARTED AND ALARM #18 SYSTEM PRESSURE ALARM X5 UNDER 200ML WHOLE BLOOD PROCESSED. THERAKOS TECHNICAL SUPPORT CONTACTED AND RN ADVISED TO END TREATMENT AND GIVE BACK BLOOD COLLECT. NEW TREATMENT STARTED ON NEW MACHINE WITH NEW KIT. PATIENT'S VITALS CHECKED PRIOR TO STARTING NEW TREATMENT AND THEY WERE WITHIN NORMAL VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAKOS PHOTOPHERESIS KIT SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL LNR THERAKOS, INC. * A313/108

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR