BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4887388 · Received July 2, 2015

    Report

    Report Number
    2523595-2015-00187
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 12, 2015
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A REVIEW OF KIT LOT D318 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 NONCOFORMANCES RELATED TO THE COMPLAINT WERE NOTED. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, DRIVE TUBE LEAK/BREAK AND ALARM #7: BLOOD LEAK? (CENTRIFUGE CHAMBER). NO TRENDS WERE IDENTIFIED FOR THESE COMPLAINT CATEGORIES. A CORRECTIVE AND PREVENTIVE ACTION WAS INITIATED FOR COMPLAINT CATEGORY, DRIVE TUBE LEAK/BREAK. SERVICE ORDER (B)(4) WAS COMPLETED. THE SERVICE TECHNICIAN CLEANED THE REMAINING BLOOD FROM THE CENTRIFUGE. THE CENTRIFUGE PRESSURE TRANSDUCER WAS REPLACED AND SYSTEM CHECKOUT WAS PERFORMED. NO FURTHER ACTION NECESSARY. A PHOTO ANALYSIS WAS CONDUCTED. REVIEW OF THE PHOTOGRAPH CONFIRMED THE REPORTED LEAK. FURTHER ANALYSIS FOUND THE ROOT CAUSE OF THE LEAK WAS DELAMINATION OF THE UPPER BEARING STOP FROM THE DRIVE TUBE. THE ANALYSIS WAS UNABLE TO DETERMINE IF THE LEAK SITE WAS AT THE UPPER BEARING, OR AT THE MIDDLE OF THE DRIVE TUBE. REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY RELATED NONCONFORMANCES. THERAKOS AND THE MANUFACTURER HAVE INITIATED CORRECTIVE ACTIONS TO ADDRESS POTENTIAL ROOT CAUSES OF DRIVE TUBE AND BEARING STOP DELAMINATION. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. SHOULD A TREND ARISE, FURTHER ACTION WILL BE TAKEN. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A LEAK IN THE DRIVE TUBE AFTER 235ML PROCESSED. ALARM #7: BLOOD LEAK? (CENTRIFUGE CHAMBER) ALARM OCCURRED, AND CUSTOMER NOTED A LEAK COMING FROM THE UPPER DRIVE TUBE BEARING. TREATMENT WAS ABORTED. SERVICE ORDER, SRV-002135, WAS DISPATCHED TO CLEAN THE INSTRUMENT. PATIENT TREATMENT WAS RESTARTED ON A DIFFERENT INSTRUMENT. THE CUSTOMER RETURNED A PICTURE FOR INVESTIGATION. CASE WAS UPDATED ON JUNE 15, 2015: THE CUSTOMER REPORTED THAT THE PATIENT'S HGB ON (B)(6) 2015 WAS 10.6; NO MEDICAL INTERVENTION WAS REQUIRED OR PROVIDED POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430178 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS INC. D318-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR