BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 6124695 · Received November 23, 2016

    Report

    Report Number
    2523595-2016-00266
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    October 27, 2016
    Report Date
    November 23, 2016
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A BATCH RECORD REVIEW OF KIT LOT E342 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 CATEGORIES, ALARM #7: BLOOD LEAK (CENTRIFUGE CHAMBER), CENTRIFUGE BOWL LEAK/BREAK, AND DRIVE TUBE LEAK/BREAK. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. AN ISSUE REVIEW WAS OPENED FOR COMPLAINT CATEGORY, CENTRIFUGE BOWL LEAK/BREAK. SERVICE ORDER REPORT, #(B)(4), FEEDBACK: THE SERVICE TECHNICIAN CLEANED THE INSTRUMENT AND REPLACED THE TWO DRIVE TUBE RETAINER CLIPS AND ALSO THE CENTRIFUGE LEAK DETECTOR STRIP. THE SYSTEM CHECKOUT PROCEDURE WAS THEN SUCCESSFULLY PERFORMED. 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT AN ALARM #7: BLOOD LEAK (CENTRIFUGE CHAMBER) ALARM. THE CUSTOMER STATED THAT A COMBINATION CENTRIFUGE BOWL LEAK/BREAK AND DRIVE TUBE LEAK/BREAK OCCURRED AT THE START OF THE TREATMENT. THE CUSTOMER REPORTED THAT THE TREATMENT WAS ABORTED WITH NO BLOOD/PRODUCTS RETURNED TO THE PATIENT. THE CUSTOMER STATED THAT THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER REPORTED THAT THERE WERE NO ALARMS PRIOR TO THE BREAK. SERVICE WAS REQUESTED. THE KIT WAS NOT RETURNED FOR INVESTIGATION AS IT HAD ALREADY BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776776 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC E342-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR