BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, PROCEDURAL, CELL EX, ECP

    MDR report key: 2399586 · Received December 23, 2011

    Report

    Report Number
    2399586
    Event Type
    Malfunction
    Date Received
    December 23, 2011
    Date of Event
    November 23, 2011
    Report Date
    December 23, 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

    WHEN PREPARING TO LOAD THE KIT INTO CELL EX INSTRUMENT TO TREAT A GRAFT VERSUS HOST DISEASE (GVHD) PATIENT IN THE PEDIATRIC ICU (PICU), THE NURSE NOTICED THE ANTICOAGULANT TUBING WAS SIGNIFICANTLY KINKED. THIS WAS NEAR THE TUBING ORGANIZER AND THE NURSE WAS UNABLE TO MASSAGE THE KINK OUT OF THE TUBING. THE KIT WAS NOT PRIMED AND WAS NOT USED FOR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT, PROCEDURAL, CELL EX, ECP CELL EX PROCEDURAL KIT FOR ECP LNR THERAKOS * Z317

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR