BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 6101052 · Received November 14, 2016

    Report

    Report Number
    2523595-2016-00252
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 17, 2016
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    UDI-DI
    10705030100009
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A BATCH RECORD REVIEW OF KIT LOT E207 WAS CONDUCTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. THE (B)(4) LOT NUMBER WAS NOT PROVIDED AS IT WAS NOT ADMINISTERED. HOWEVER, A REVIEW OF ALL (B)(4) LOTS MANUFACTURED SINCE JANUARY 2013 WAS PERFORMED. NO TRENDS OR NONCONFORMANCES RELATED TO THE COMPLAINT WERE NOTED. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, TUBING LEAK. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. SERVICE ORDER REPORT, #(B)(4), FEEDBACK: THE SERVICE TECHNICIAN CLEANED THE INSTRUMENT AND REPLACED ONE PUMP HEAD. THE SERVICE TECHNICIAN THEN CALLIBRATED ALL THE PUMPS AND SUCCESSFULLY COMPLETED THE SYSTEM CHECKOUT PROCEDURE. 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). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COLLECT PUMP TUBING SEGMENT "CRACKED" AFTER 1300ML OF WHOLE BLOOD PROCESSED. THE CUSTOMER STATED THAT THE TREATMENT WAS ABORTED WITH NO BLOOD/PRODUCTS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT WAS IN STABLE CONDITION. SERVICE WAS REQUESTED. THE KIT WAS NOT RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750139 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC E207-KIT 10705030100009

    Patients

    Seq Age Sex Outcome Treatment
    1