BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX INSTRUMENT

    MDR report key: 2829584 · Received October 29, 2012

    Report

    Report Number
    2829584
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 25, 2012
    Manufacturer
    THERAKOS INC.
    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

    CELLEX INSTRUMENT # 40156 HAD INCREASED AIR IN THE RETURN LINE -- THE OPTICAL READING STATED THAT 9ML WAS IN THE RETURN BAG EVEN THOUGH THE RETURN BAG WAS COMPLETELY EMPTY. AT ABOUT 100 ML WHOLE BLOOD PROCESSED SWITCHED FROM DOUBLE TO SINGLE NEEDLE MODE. THERAKOS CONSULTED -- NS BOLUSES & REDIRECTING THE AIR DETECTOR LINES BUT UNABLE TO RESOLVE THE PROBLEM. TREATMENT ABORTED & COLLECTED BLOOD RETURNED TO THE PATIENT. PATIENT REMAINED STABLE & WITHOUT COMPLAINTS THROUGHOUT THE TREATMENT. PATIENT RECEIVED A TREATMENT ON A DIFFERENT CELLEX INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELLEX INSTRUMENT SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL LNR THERAKOS INC. UNK A312/502

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR