BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS XTS PHOTOPHERESIS SYSTEM

    MDR report key: 5045567 · Received September 1, 2015

    Report

    Report Number
    2523595-2015-00222
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    August 4, 2015
    Report Date
    August 4, 2015
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    UDI-DI
    10705030100016
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A REVIEW OF KIT LOT C748 WAS PERFORMED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET RELEASE REQUIREMENTS. THE UVADEX LOT NUMBER WAS NOT PROVIDED, SINCE UVADEX WAS NOT ADMINISTERED. HOWEVER, A REVIEW OF ALL UVADEX LOTS MANUFACTURED SINCE JANUARY 2013 WAS PERFORMED. NO TRENDS OR NONCONFORMANCES RELATED TO THE COMPLAINT WERE NOTED. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, NOISE, OCCLUSION SYSTEM ALARM, LEAK CENTRIFUGE ALARM, AND CENTRIFUGE BOWL LEAK/BREAK. NO TRENDS WERE DETECTED. NO CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED FOR THESE COMPLAINT CATEGORIES. FEEDBACK FROM SERVICE ORDER, SRV-002325, IS STILL PENDING. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THIS FEEDBACK IS AVAILABLE. THIS ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION; THEREFORE IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECIFICATIONS BASED SOLELY ON INFORMATION PROVIDED BY THE CUSTOMER. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. SHOULD A TREND ARISE, FURTHER ACTION WILL BE TAKEN THROUGH THE THERAKOS CAPA /CONTINUOUS IMPROVEMENT PROCESS. (B)(4). NOT RETURNED.

    Additional Manufacturer Narrative · 1

    FEEDBACK FROM SERVICE ORDER, (B)(4): SERVICE WAS PERFORMED AND THE SERVICE ENGINEER TOOK APART THE CENTRIFUGE AND CLEANED PAST BLOOD LEAK. CHECKOUT PROCEDURE WAS PERFORMED WITH SATISFACTORY RESULTS. NO FURTHER ACTION WAS NECESSARY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER WAS IN THE 6TH CYCLE OF AN XTS PROCEDURE WHEN SHE HEARD A GRINDING SOUND COMING FROM THE CENTRIFUGE BOWL. THE CUSTOMER THEN PAUSED THE PROCEDURE AND CALLED THE HOTLINE. WHILE ON THE PHONE WITH CLINICAL SERVICES SPECIALIST, THE CUSTOMER PROCEEDED AND A SYSTEM OCCLUSION ALARM OCCURRED. NO KINKS OR CLOTS WERE OBSERVED IN THE KIT. SHORTLY AFTER THE SYSTEM OCCLUSION ALARM OCCURRED, A BLOOD LEAK ALARM OCCURRED. CUSTOMER REPORTED A SMALL AMOUNT OF BLOOD VISIBLE IN THE CENTRIFUGE CHAMBER AND 3-4 ML OF BLOOD WAS VISUALIZED IN THE BOWL OVERFLOW BAG. THE TREATMENT WAS ABORTED. PATIENT WAS STABLE AND THE HCT AFTER TREATMENT WAS HIGHER THAN THE PREVIOUS HCT, SO THE PHYSICIANS WERE NOT CONCERNED. THE PATIENT WAS SENT HOME FOR THE DAY WITHOUT A SUCCESSFUL TREATMENT. THE CUSTOMER ELECTED NOT TO RETURN THE KIT FOR INVESTIGATION. THE CUSTOMER CALLED BACK LATER THE SAME DAY AND REQUESTED SERVICE DUE TO RESIDUAL BLOOD. CSS DISPATCHED SERVICE ORDER #2325.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578889 THERAKOS XTS PHOTOPHERESIS SYSTEM XTS LNR THERAKOS INC. C748 - KIT 10705030100016

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR