BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, THERAKOS, CELLEX PHOTOPHERESIS

    MDR report key: 2618461 · Received June 9, 2012

    Report

    Report Number
    2618461
    Event Type
    Malfunction
    Date Received
    June 9, 2012
    Date of Event
    April 6, 2012
    Report Date
    June 6, 2012
    Manufacturer
    THERAKOS
    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

    THE PATIENT WAS TREATED ON THE CELLEX MACHINE FOR GRAFT VERSUS HOST DISEASE (GVHD) OF LIVER. DURING THE TREATMENT, AIR IN LINE WAS NOTED AND THERE WAS AN AIR IN LINE ALARM ON THE CELLEX MACHINE. THERAKOS WAS CALLED AND THE TREATMENT WAS ABORTED AS AIR COULD NOT BE REMOVED FROM THE MACHINE AND REPRIMED. A MANUAL RETURN OF ALL BLOOD WAS GIVEN BACK TO THE PATIENT. THE MD WAS NOTIFIED. VITAL SIGNS WERE STABLE AND A NEW TREATMENT WAS STARTED PER MD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, THERAKOS, CELLEX PHOTOPHERESIS THERAKOS CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS CELLEX A301/612

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR