BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS XTS PHOTOPHERESIS SYSTEM

    MDR report key: 4172848 · Received October 10, 2014

    Report

    Report Number
    2523595-2014-00271
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A BATCH RECORD REVIEW OF LOT C901 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, OCCLUSION PATIENT ALARM, CLOT OBSERVED, AND LEAK CENTRIFUGE ALARM. NO TRENDS WERE DETECTED FOR COMPLAINT CATEGORIES, OCCLUSION PATIENT ALARM, CLOT OBSERVED, AND LEAK CENTRIFUGE ALARM. NO CAPAS WERE INITIATED FOR EITHER OF THESE COMPLAINT CATEGORIES. THE ASSESSMENT IS BASED ON INFO 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 INFO PROVIDED BY THE CUSTOMER. 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).

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT AN OCCLUSION PATIENT ALARM. THE CUSTOMER FOUND CLOTS IN THE PATIENT LINE. WHILE THE CUSTOMER CHECKED THE OCCLUSION PATIENT ALARM, A LEAK CENTRIFUGE ALARM OCCURRED. THE LEAK CENTRIFUGE OCCURRED DURING THE BUFFY COAT COLLECTION IN CYCLE ONE AFTER APPROXIMATELY 200 ML WHOLE BLOOD PROCESSED. THE CUSTOMER FOUND A LEAK AT THE CENTRIFUGE BOWL ROTATION SEAL. THE CUSTOMER ABORTED THE TREATMENT AND DISCARDED THE VOLUME IN THE KIT WHICH WAS ABOUT 200 MLS. THE RESPONSIBLE PHYSICIAN DECIDED TO START A NEW TREATMENT WITH A NEW KIT. THE NEW TREATMENT WAS PERFORMED WITHOUT ANY PROBLEMS OR ALARMS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO SERVICE ORDER WAS GENERATED. THE KIT WAS DISCARDED AND NO PHOTOS WERE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642666 THERAKOS XTS PHOTOPHERESIS SYSTEM XTS LNR THERAKOS, INC. C901-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1