BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS XTS PHOTOPHERESIS SYSTEM

    MDR report key: 3162460 · Received June 6, 2013

    Report

    Report Number
    2523595-2013-00022
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BOTH THE RETURNED PHOTOACTIVATION MODULE AND DATA KEY WERE RECEIVED BY (B)(4) ON (B)(4) 2013. A VISUAL INSPECTION CONFIRMED THAT THE TUBING HAD PULLED AWAY FROM THE WALL OF THE BONE SOCKET FORMING A GAP IN THE BOND TO THE PHOTOACTIVATION PLATE. ANY POTENTIAL CONTRIBUTING FACTORS ARE BEING HANDLED BY THE CORRECTIVE ACTION PROCESS. THERE WAS NO REPORTED HARM TO THE PT. THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY; BUT MALFUNCTIONED IN A WAY SIMILAR TO A (B)(4) EVENT LISTED ON THE (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY OBSERVED A PHOTOACTIVATION PLATE LEAK DURING A TREATMENT PROCEDURE. ISSUE STARTED ON: (B)(6) 2013. THE TREATMENT WAS ABORTED. KIT TYPE: XT125, KIT LOT NUMBER: Z762. THE PRODUCT WAS RETURNED FOR AN INVESTIGATION. CUSTOMER STATED WHEN THE UV LID WAS RAISED DURING FINAL RETURN, THEY SAW THERE HAD BEEN A BLOOD LEAK FROM THE PHOTO ACTIVATION MODULE. CUSTOMER STATED THE TREATMENT WAS ABORTED AND THE TREATMENT VOLUME STILL IN THE KIT AT THAT TIME WAS NOT RETURNED TO THE PT. CUSTOMER ESTIMATED THE TOTAL BLOOD LOSS FOR THE PT AT ABOUT 100 TO 125 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251747 THERAKOS XTS PHOTOPHERESIS SYSTEM UVAR XTS ECP SYSTEM LNR THERAKOS 6660 Z762

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other