BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM

    MDR report key: 5085738 · Received September 17, 2015

    Report

    Report Number
    2523595-2015-00242
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 1, 2015
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    UDI-DI
    10705030100016
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM WAS USED FOR TREATMENT. KIT LOT C748 WAS REVIEWED. THERE WERE NO NON-CONFORMANCES. THIS LOT MET ALL 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 ALL COMPLAINT CATEGORIES AND NO TREND WAS DETECTED FOR CENTRIFUGE BOWL LEAK/BREAK OR LEAK CENTRIFUGE ALARM. NO CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED FOR COMPLAINT CATEGORIES CENTRIFUGE BOWL LEAK/BREAK OR LEAK CENTRIFUGE ALARM. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED BY THE CUSTOMER FOR INVESTIGATION, THEREFORE IT COULD NOT BE DETERMINED IF THE SPECIFIC PRODUCT MET SPECIFICATION. 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 TO REPORT CENTRIFUGE LEAK ALARM DURING 3RD CYCLE. CUSTOMER OPENED CENTRIFUGE COVER, AND STATED SHE COULD NOT SEE OR FEEL ANY LEAKED FLUID. CUSTOMER SAID WHEN SHE WIPED A DRY GAUZE AROUND THE SIDE WALL OF THE CENTRIFUGE CHAMBER, SHE REPORTED THERE WAS FINE RED DUST THAT COLLECTED ON THE GAUZE PAD. CUSTOMER REPORTED THE CENTRIFUGE BOWL NECK WAS FIXED IN PLACE/WILL NOT TURN. CUSTOMER ABORTED THE TREATMENT AND MANUALLY RETURNED FLUID IN KIT TO PATIENT. PATIENT REPORTED TO BE STABLE. CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617295 THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM XTS LNR THERAKOS, INC C748 - KIT 10705030100016

    Patients

    Seq Age Sex Outcome Treatment
    1