BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX

    MDR report key: 3110604 · Received May 10, 2013

    Report

    Report Number
    3110604
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    March 26, 2013
    Report Date
    May 9, 2013
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ECP TREATMENT WAS COMPLETED. THIS NURSE NOTED THAT DURING ELUTRIATION THERE WAS EITHER PINCHED TUBING OR SOME KIND OF KINK WITHIN THE THE PUMP TUBING ORGANIZER ITSELF. IT APPEARED THAT THIS KINK OR WAS LOCATED IN THE PLASMA LINE GOING FROM THE CENTRIFUGE TO THE RETURN BAG. DURING ELUTRIATION IT APPEARED THERE WAS PLATELET CLUMPING IN THIS AREA OF THE KINK AND CAUSED SOME BACKING UP FLUID IN THIS AREA OF TUBING. THIS NURSE FEELS THAT THIS MAY HAVE CAUSED A SYSTEM PRESSURE ALARM DURING ELUTRIATION, AND THERE WAS A NEED TO PHOTOACTIVATE THE CELLS EARLY IN ORDER TO COMPLETE THIS TREATMENT. THE PHOTOACTIVATION TIME WAS LOW; 8 MINUTES + 40 SECONDS. TREATMENT WAS COMPLETED WITHOUT INCIDENT TO THE PATIENT. THERAKOS CONTACTED AND THEY REQUESTED KIT TO BE SENT BACK FOR ASSESSMENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ECP (PHOTOPHERESIS).DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207474 THERAKOS CELLEX PHOTOPHERESIS, EXTRACORPOREAL PROCEDURAL KIT LNR THERAKOS, INC. * B303

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR