BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREATMENT, PHOTOPHERESIS, EXTRACORPOREAL

    MDR report key: 2250841 · Received August 28, 2011

    Report

    Report Number
    2250841
    Event Type
    Malfunction
    Date Received
    August 28, 2011
    Date of Event
    July 26, 2011
    Report Date
    August 28, 2011
    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

    EXPERIENCED MULTIPLE SYSTEM OCCLUSION ALARMS AT THE START OF ELUTRIATION AND PLASMA PHASES OF THE EXTRACORPOREAL PHOTOPHORESIS (ECP) TREATMENT USING THE XTS INSTRUMENT. THE SERIAL NUMBER WAS (B)(6) AND THE KIT LOT NUMBER WAS Z738. TROUBLE-SHOOTING INCLUDED: MULTIPLE SALINE BOLUSES, POWERING INSTRUMENT OFF AND ON, INCREASED ANTICOAGULANT RATION TO EIGHT TO ONE IN CYCLE ONE (AFTER THREE SUCH ALARMS). NO CLOTS WERE VISIBLE IN THE KIT DURING ECP OR AFTER UNLOADING THE KIT POST ECP. CONFERRED WITH THERAKOS TECH SUPPORT; DECREASED THE NUMBER OF CYCLES FROM THE FIVE PLANNED TO THREE IN ORDER TO AVOID AN INABILITY TO COMPLETE THE ECP IF WE WERE UNABLE TO CLEAR THE ALARMS. WE WERE ABLE TO COMPLETE THE ECP. THE PT RECEIVED THE TREATMENT, BUT WITH FEWER CYCLES THAN CALCULATIONS INDICATED. THE KIT WAS SAVED FOR BIOMED AND THERAKOS EVLAUATION. THE PT WAS UNHARMED AND TOLERATED ECP WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREATMENT, PHOTOPHERESIS, EXTRACORPOREAL EXTRACORPOREAL PHOTOPHERESIS TREATMENT (ECP) LNR THERAKOS * Z738

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR