BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4791684 · Received May 22, 2015

    Report

    Report Number
    2523595-2015-00165
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 6, 2015
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A BATCH RECORD REVIEW OF KIT LOT D107 WAS CONDUCTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. THE UVADEX LOT NUMBER WAS NOT PROVIDED. 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, ALARM #18: SYSTEM PRESSURE, ALARM #7: BLOOD LEAK (CENTRIFUGE CHAMBER) AND CENTRIFUGE BOWL LEAK/BREAK. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. CORRECTIVE AND PREVENTIVE ACTIONS WERE INITIATED FOR COMPLAINT CATEGORY, ALARM #18: SYSTEM PRESSURE AND THEY ARE NOW CLOSED. A CORRECTIVE AND PREVENTIVE ACTION WAS INITIATED FOR COMPLAINT CATEGORY, CENTRIFUGE BOWL LEAK/BREAK. NO CORRECTIVE AND PREVENTIVE ACTION WAS INITIATED FOR COMPLAINT CATEGORY, ALARM #7: BLOOD LEAK (CENTRIFUGE CHAMBER). PRODUCT RETURN ANALYSIS FEEDBACK: A PHOTO ANALYSIS WAS CONDUCTED FOR THIS COMPLAINT. A REVIEW OF THE PHOTOGRAPHS CONFIRMED THE BLOOD LEAK HOWEVER, THE LOCATION OF THE LEAK COULD NOT BE VERIFIED. THE ROOT CAUSE OF THE LEAK COULD NOT BE DETERMINED. ALL DRIVE TUBES AND CENTRIFUGE BOWLS ARE 200% LEAK AND OCCLUSION TESTED DURING MANUFACTURING. NO MANUFACTURING DEFECTS WERE IDENTIFIED DURING THE EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY RELATED NONCONFORMANCES. 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. MEDDRA CODES: LT-DEVICE MALFUNCTION-10063829 (B)(4). TTQMS: 15054 RR: 15426 S.K. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ALARM # 18: SYSTEM PRESSURE ALARM AT 1300 ML OF WHOLE BLOOD PROCESSED. WHEN THE BOWL STOPPED, THE CUSTOMER SAW BLOOD SPREADING INTO THE CENTRIFUGE CHAMBER. THE CUSTOMER OPENED THE CENTRIFUGE DOOR AND VERIFIED A BOWL LEAK ON THE TOP OF THE BOWL. THE TREATMENT WAS ABORTED AND NO BLOOD WAS RETURNED TO THE PATIENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE CUSTOMER REMOVED THE KIT THEN CLEANED THE CENTRIFUGE CHAMBER AND DOOR. THE CUSTOMER POWERED ON THE INSTRUMENT AND IT WAS READY FOR PRIME. ON (B)(6) 2015, THE CUSTOMER CONFIRMED THAT A BLOOD LEAK ALARM DID OCCUR. PICTURES WERE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335955 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC D107-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1