BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4903347 · Received July 9, 2015

    Report

    Report Number
    2523595-2015-00202
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 26, 2015
    Report Date
    June 26, 2015
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A BATCH RECORD REVIEW OF LOT D111 WAS CONDUCTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET 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 NONCONFORMANCES RELATED TO THE COMPLAINT WERE NOTED. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, CENTRIFUGE BOWL LEAK/BREAK. NO TREND WAS DETECTED FOR THIS COMPLAINT CATEGORY. HOWEVER, A CORRECTIVE AND PREVENTIVE ACTION WAS INITIATED FOR COMPLAINT CATEGORY, CENTRIFUGE BOWL LEAK/BREAK. SERVICE ORDER, (B)(4), FEEDBACK: THE SERVICE TECHNICIAN CLEANED THE INSTRUMENT AND REPLACED BOTH THE LEAK DETECTOR AND THE DRIVE TUBE RETAINER CLIPS. THE TECHNICIAN THEN SUCCESSFULLY PERFORMED THE SYSTEM CHECKOUT PROCEDURE. NO FURTHER ACTION REQUIRED. THE ASSESSMENT IS BASED ON INFORMATION 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 INFORMATION 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). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BOWL LEAK AT THE BEGINNING OF THE PROCEDURE. THE TREATMENT WAS ABORTED AND NO BLOOD WAS RETURNED TO THE PATIENT. THE CENTRIFUGE LEAK SENSOR WAS DAMAGED. ON (B)(6) 2015, THE CUSTOMER STATED THAT THEY COULD NOT REMEMBER IF A LEAK ALARM OCCURRED. SERVICE ORDER, (B)(4), WAS GENERATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447528 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC D111-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR