BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS XTS PHOTOPHERESIS SYSTEM

    MDR report key: 5019029 · Received August 20, 2015

    Report

    Report Number
    2523595-2015-00224
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 6, 2015
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    UDI-DI
    10705030100016
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A REVIEW OF KIT LOT C757 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, LEAK CENTRIFUGE ALARM AND CENTRIFUGE BOWL LEAK/BREAK. NO TRENDS WERE DETECTED. NO CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED FOR COMPLAINT CATEGORIES, LEAK CENTRIFUGE ALARM OR CENTRIFUGE BOWL LEAK/BREAK. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED BY THE CUSTOMER FOR 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).

    Description of Event or Problem · 1

    CUSTOMER CALLED AND REPORTED CENTRIFUGE LEAK ALARM AT END OF THE FIRST CYCLE DURING BUFFY COAT COLLECTION. CLINICAL SERICES SPECIALIST ADVISED TO CHECK THE CENTRIFUGE BOWL FOR LEAK. CUSTOMER STATED THAT SHE FOUND FLUID IN THE CENTRIFUGE BOWL CHAMBER, BUT COULD NOT LOCATE THE LEAK IN THE CENTRIFUGE BOWL. CSS ADVISED TO ABORT THE TREATMENT WITHOUT RETURNING THE VOLUME. CSS ADVISED THE CUSTOMER TO INFORM THE RESPONSIBLE PHYSICIAN ABOUT THE CETRIFUGE BOWL LEAK. CUSTOMER ELECTED NOT TO RETURN THE KIT TO THERAKOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551240 THERAKOS XTS PHOTOPHERESIS SYSTEM XTS LNR THERAKOS INC. C757 - KIT 10705030100016

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR