BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS CELLEX

    MDR report key: 3845925 · Received May 28, 2014

    Report

    Report Number
    MW5036410
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A PHOTOPHERESIS PROCEDURE, AFTER 15-20 MINUTES INTO THE PROCEDURE, IT WAS NOTICED THAT BLOOD WAS BEGINNING TO POOL ON THE INSTRUMENT DECK. THE REAR PRESSURE SENSOR WAS DISLODGED FROM THE INSTRUMENT. THE PRESSURE SENSOR CLIPS APPEAR BROKEN. THE BLOOD APPEARS TO BE COMING FROM THE PRESSURE SENSOR. THE BLOOD IN THE CENTRIFUGE BOWL WAS NOT RETURNED TO THE PT. THE PT EXPERIENCED A 180 ML BLOOD LOSS. PROCEDURE KITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314815 THERAKOS CELLEX THERAKOS CELLEX PHOTOPHERESIS LNR THERAKOS, INC. B353/88

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention