BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTS PHOTOPHERESIS SYSTEM

    MDR report key: 6191724 · Received December 20, 2016

    Report

    Report Number
    2523595-2016-00280
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 21, 2016
    Report Date
    December 20, 2016
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    UDI-DI
    20705030200027
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A BATCH RECORD REVIEW OF KIT LOT E721 WAS CONDUCTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, CENTRIFUGE BOWL LEAK/BREAK AND LEAK CENTRIFUGE ALARM. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION; THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECIFICATION BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED. (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT A CENTRIFUGE BOWL LEAK/BREAK AND A LEAK CENTRIFUGE ALARM. THE CUSTOMER STATED THAT THE LEAK ORIGINATED AT THE TOP OF THE CENTRIFUGE BOWL AND HAD SPILLED INTO THE CENTRIFUGE CHAMBER. THE CUSTOMER REPORTED THAT THERE WAS A CRACK IN THE DOME AT THE TOP OF THE CENTRIFUGE BOWL, WHERE THE TUBING INLET AND OUTLET LINES MEET. THE CUSTOMER STATED THAT THE LEAK OCCURRED DURING THE THIRD CYCLE OF THE TREATMENT. THE CUSTOMER REPORTED THAT THE TREATMENT WAS ABORTED WITH NO RETURN OF BLOOD/PRODUCTS TO THE PATIENT. THE CUSTOMER STATED THAT THE PATIENT WAS IN STABLE CONDITION AND WAS CURRENTLY UNDERGOING A NEW TREATMENT ON ANOTHER INSTRUMENT. THE CUSTOMER REPORTED THAT THEY HAVE CLEANED THE INSTRUMENT, AND DID NOT NEED SERVICE AT THIS TIME. THE KIT WAS NOT RETURNED FOR INVESTIGATION AS IT HAD ALREADY BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840293 XTS PHOTOPHERESIS SYSTEM XTS PHOTOPHERESIS SYSTEM LNR THERAKOS, INC NOT APPLICABLE E721 20705030200027

    Patients

    Seq Age Sex Outcome Treatment
    1