BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX

    MDR report key: 6137756 · Received December 1, 2016

    Report

    Report Number
    6137756
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    August 16, 2016
    Report Date
    November 19, 2016
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE THERAKOS CELLEX PHOTOPHERESIS UNIT WAS GIVING FALSE "AIR IN LINE" ERROR MESSAGES DURING THE PRIMING PHASE (PRE-USE) OF TREATMENT. AFTER MUCH TROUBLESHOOTING, IT WAS DETERMINED THAT RF INTERFERENCE FROM A T-MOBILE ANTENNA WAS THE SOURCE OF RF THAT WAS CREATING THE FALSE ERROR MESSAGE TO APPEAR. THIS ANTENNA IS LOCATED ACROSS THE STREET, APPROX. 50 FEET AWAY FROM THE PATIENT ROOM WHERE TREATMENT WAS TO BE DONE. IT HAS YET TO BE DETERMINED IF THE PROBLEM IS CAUSED BY AN OVERLY STRONG SIGNAL BEING SENT OUT BY THE ANTENNA OR IF THE CELLEX UNIT IS OVERLY SENSITIVE TO INADVERTENT RF. MANUFACTURER RESPONSE FOR PHOTOPHERESIS UNIT, CELLEX (PER SITE REPORTER): THE VENDOR BROUGHT OUT ANOTHER CELLEX. IT TOO WAS GIVING FALSE "AIR IN LINE" ERROR MESSAGES. THEY WERE VERY HELPFUL IN TROUBLESHOOTING THE PROBLEM. (B)(6) CALLED THERAKOS TO DISCUSS THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788547 CELLEX SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL LNR THERAKOS, INC. CELLEX

    Patients

    Seq Age Sex Outcome Treatment
    1 NO OTHER THERAPIES| NO.