BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4561883 · Received February 27, 2015

    Report

    Report Number
    2523595-2015-00050
    Event Type
    Malfunction
    Date Received
    February 27, 2015
    Date of Event
    February 9, 2015
    Report Date
    February 9, 2015
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT C351 WAS PERFORMED AND THERE WERE NO NONCONFORMITIES ASSOCIATED WITH THIS LOT. THIS LOT MET RELEASE REQUIREMENTS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, PTO LEAK, ALARM #17: RETURN PRESSURE, AND CLOT OBSERVED. THERE WERE NO TRENDS DETECTED. CAPA (B)(4) WAS INITIATED FOR COMPLAINT CATEGORY ALARM #17. THIS CAPA HAS BEEN CLOSED. NO CAPAS WERE INITIATED FOR PTO LEAK OR CLOT OBSERVED. THE KIT AND A PHOTO WERE RETURNED FOR ANALYSIS. THE DRIED BLOOD INSIDE THE PTO WAS VERIFIED UPON REVIEW OF THE RETURNED KIT. VARIOUS LEAK TESTS WERE PERFORMED ON THE FLUID CIRCUITS WITHIN THE RETURNED KIT AND NO LEAKS WERE IDENTIFIED. AS SUCH, THE ROOT CAUSE OF THE DRIED BLOOD WAS NOT DETERMINED FROM THE ANALYSIS. NO MFG DEFECTS WERE IDENTIFIED DURING THE ANALYSIS. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. SHOULD A TREND ARISE, FURTHER ACTION WILL BE TAKEN. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED FLUID LEAKING FROM TUBING RIGHT ABOVE THE FILTER ON THE PUMP TUBING ORGANIZER. CUSTOMER NOTED THE LEAK DURING PHOTOACTIVATION. CSS ASKED IF IT WAS THE PUMP TUBING SEGMENT ABOVE THE FILTER, CUSTOMER SAID NO, NONE OF THE PUMP TUBING SEGMENTS WERE LEAKING. IT WAS A TUBING FROM INSIDE THE PUMP TUBING ORGANIZER. CUSTOMER STATED THEY COMPLETED TREATMENT PROCEDURE AND RETURNED ALL BLOOD/PRODUCTS TO PT. CSS ASKED IF THERE WERE ANY ALARMS DURING THE TREATMENT PROCEDURE. CUSTOMER STATED THERE WERE SOME RETURN PRESSURE ALARMS, BUT THEY WERE ABLE TO CLEAR THE ALARM BUT LOWER THE RETURN RATE. CSS ASKED IF THERE WAS ANY CLOTTING OR OCCLUSION NOTED IN ANY PART OF THE KIT. CUSTOMER STATED THERE WAS CLUMPING IN THE CENTRIFUGE BOWL. CSS INFORMED CUSTOMER THAT WHEN A FLUID LEAK, CLOTTING, OR OCCLUSION IS OBSERVED IN ANY PART OF THE KIT, THERAKOS RECOMMENDS KIT BE ABORTED WITH NO RETURN OF BLOOD/PRODUCTS TO THE PT. CUSTOMER STATED SHE UNDERSTOOD. CSS SUGGESTED CUSTOMER CONTACT ATTENDING PHYSICIAN TO INFORM HIM/HER. CUSTOMER STATED PHYSICIAN HAS BEEN CONTACTED. THE KIT AND A PHOTO WERE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140687 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. C351/603

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR