BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS XTS PHOTOPHERESIS SYSTEM

    MDR report key: 3894770 · Received May 19, 2014

    Report

    Report Number
    2523595-2014-00135
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF C705 WAS PERFORMED AND THERE WAS ONE NON-CONFORMANCE ASSOCIATED WITH THIS LOT. (B)(4) BONDING FAILURE IN A PREVIOUS KIT LOT DUE TO A CHANNEL/PATH THROUGH THE TUBING. THE TUBING LOT USED WAS USED IN C705 BUT WAS NOT THE CAUSE OF THE LEAK. THIS LOT MET RELEASE REQUIREMENTS. THIS ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THIS INVESTIGATION. THE ACTUAL PRODUCT WAS NOT RETURNED. AN INVESTIGATION WAS CONDUCTED ON A VIDEO SUBMITTED BY THE CUSTOMER. NO PHYSICAL ITEM WAS RETURNED FOR INVESTIGATION. THEREFORE, IT COULD NOT BE DETERMINED IF THIS SPECIFIC PRODUCT MET SPECS. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED THROUGH THE CAPA/CONTINUOUS IMPROVEMENT PROCESS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A LEAK DURING PRIME, SITUATED IN THE PT LINE. FURTHER INFO WAS REPORTED ON THE FOLLOWING DAY: THE PT LINE WAS CONNECTED TO THE NEEDLE, AFTER PUSHING THE START BUTTON, CUSTOMER OBSERVED A BLOOD LEAK AT THE CONNECTION AND THE KIT TAKES AIR IN THE PT. AFTER THAT THEY DISCONNECTED AND TRIED AGAIN, BUT THE SAME ISSUE HAPPENED AT EVERY ATTEMPT: 3 OR 4 TIMES. THEY CONNECTED TO A NEW NEEDLE AND PUSHED SALINE, BUT THE SAME PROBLEM RECURRED; TREATMENT WAS ABORTED. PT CONDITION WAS GOOD. PT HAD A SUCCESSFUL TREATMENT ON THE SAME DAY. CUSTOMER SUBMITTED VIDEO FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296120 THERAKOS XTS PHOTOPHERESIS SYSTEM LNR THERAKOS, INC. C705 - KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK