BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS CELLEX EXTRACORPOREAL PHOTOPHERESIS PROCEDURAL KIT

    MDR report key: 2771832 · Received October 1, 2012

    Report

    Report Number
    MW5027148
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 19, 2012
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A CELLEX PHOTOPHERESIS PEDIATRIC BLOOD PRIME WAS BEING PERFORMED ON A (B)(6) PT WEIGHING (B)(6) WHEN THE EVENT OCCURRED. THE PHOTOPHERESIS PROCEDURE WAS INITIATED USING HER DUAL LUMEN POWER PICC IN HER LEFT SUBCLAVIAN. ONE UNIT OF PACKED RED BLOOD CELLS THAT WAS IRRADIATED AND LEUKOREDUCED WAS USED FOR THE PROCEDURE. APPROX. AN HOUR INTO THE PROCEDURE ¿AIR DETECTED¿ IN THE CENTRIFUGE BOWL OCCURRED MULTIPLE TIMES. AIR WAS PURGED FROM THE CENTRIFUGE SUCCESSFULLY, BUT PROCEDURE WAS PROLONGED AND TOOK 3:03 HRS TO COMPLETE. THE PT WAS MONITORED CLOSELY AND TOLERATED THE PROCEDURE WELL. FLUID BALANCE +40 ML. DATE OF USE: (B)(6) 2012. REASON FOR USE: GRAFT VERSUS HOST DISEASE OF THE GUT AND SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAKOS CELLEX EXTRACORPOREAL PHOTOPHERESIS PROCEDURAL KIT CELLEX KIT LNR THERAKOS INC. CLX A 312

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention