BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS XTS PHOTOPHERESIS SYSTEM

    MDR report key: 4896565 · Received July 7, 2015

    Report

    Report Number
    2523595-2015-00200
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 8, 2015
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A BATCH RECORD REVIEW OF KIT LOT C739 WAS CONDUCTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. THE UVADEX LOT NUMBER WAS NOT PROVIDED AS IT WAS NOT ADMINISTERED. HOWEVER, A REVIEW OF ALL UVADEX LOTS MANUFACTURED SINCE JANUARY 2013 WAS PERFORMED. NO TRENDS OR NONCOFORMANCES RELATED TO THE COMPLAINT WERE NOTED. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, AIR DETECTED ALARM AND TUBING LEAK. NO TREND WAS DETECTED FOR THESE COMPLAINT CATEGORIES. NO CORRECTIVE AND PREVENTIVE ACTIONS WERE INITIATED FOR COMPLAINT CATEGORIES, AIR DETECTED ALARM AND TUBING LEAK. PRODUCT RETURN ANALYSIS FEEDBACK: A PHOTO ANALYSIS WAS CONDUCTED FOR THIS COMPLAINT. A REVIEW OF THE PHOTOGRAPHS CONFIRMED A LEAK AT THE MALE LUER. HOWEVER, THE ROOT CAUSE OF THE LUER LEAK COULD NOT BE DETERMINED BASED SOLELY ON THE AVAILABLE INFORMATION. A MATERIAL TRACE OF LOT C739 FOR THE TWO MATING PARTS FOUND NO NONCONFORMANCES. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY RELATED NONCONFORMANCES. THIS LOT PASSED ALL LOT RELEASE TESTING. NO MANUFACTURING DEFECTS WERE IDENTIFIED. HOWEVER, THERAKOS IS REPORTING THIS EVENT OUT OF AN ABUNDANCE OF CAUTION. ALL COMPLAINTS ARE REVIEWED WITH THE DEPARTMENT OPERATORS TO MAKE THEM AWARE OF ANY DEFECTS THAT CAN OCCUR. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED THROUGH THE CAPA/CONTINUOUS IMPROVEMENT PROCESS. (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THROUGH A DISTRIBUTOR, A DEFECT ON THE LUER CONNECTION OF THE COLLECTION LINE. WHEN CONNECTING THE COLLECTION LINE TO THE PATIENT, AIR BUBBLES WERE OBSERVED DURING THE FIRST EXTRACTION. THE MACHINE IMMEDIATELY ALARMED AND THE PROCEDURE WAS TEMPORARILY INTERRUPTED. THE CUSTOMER REPORTED THAT THE LUER CONNECTION COVER HAD REQUIRED A GREATER FORCE TO BE REMOVED. ON (B)(6) 2015, THE DISTRIBUTOR REPORTED THAT THE TREATMENT WAS ABORTED, AND THAT THE BLOOD WAS RETURNED TO THE PATIENT. THERE WAS NO LOSS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO SERVICE ORDER WAS GENERATED. PICTURES WERE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438155 THERAKOS XTS PHOTOPHERESIS SYSTEM XTS LNR THERAKOS, INC C739-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1