BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS XTS PHOTOPHERESIS SYSTEM

    MDR report key: 4152516 · Received October 6, 2014

    Report

    Report Number
    2523595-2014-00270
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE ORDER (B)(4) WAS DISPATCHED. TECH PERFORMED DIAGNOSTICS AND FOUND A BAD FSC BOARD. A NEW FSC BOARD WAS INSTALLED. TECH PERFORMED BOWL OPTICS AND THERMOCOUPLE CALIBRATION. THE NEW BOARD SUCCESSFULLY COMPLETED SYSTEM CHECKOUT PROCEDURE. AT THE TIME OF THE INVESTIGATION, NO TREND WAS DETECTED FOR COMPLAINT CATEGORY LAMP FAILURE ALARM OR SMELL. THERE WAS NO CAPA INITIATED FOR COMPLAINT CATEGORY LAMP FAILURE ALARM OR SMELL. THE PRODUCT WAS NOT RETURNED FOR FURTHER ANALYSIS; THEREFORE, IT COULD NOT BE DETERMINED IF THIS SPECIFIC PRODUCT MET SPECIFICATIONS. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED THROUGH THE CAPA/CONTINUOUS IMPROVEMENT PROCESS. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT LAMP FAILURE ALARM DURING PHOTOACTIVATION AND A BURNING SMELL. CUSTOMER EXPLAINED THAT IN THE MIDDLE OF PHOTOACTIVATION, THEY HAD A LAMP FAILURE ALARM. CUSTOMER ABORTED THE PROCEDURE AND WILL RETURN BLOOD/PRODUCTS TO THE PT. CUSTOMER STATED THERE IS NO SMOKE COMING FROM THE MACHINE. CUSTOMER STATED PT IS ALRIGHT. CUSTOMER STATED NO ONE HAS BEEN INJURED FROM THE SMELL FROM THE INSTRUMENT. CUSTOMER STATED 30 MINS WERE LEFT TO COMPLETE PHOTOACTIVATION. CUSTOMER WAS TOLD THAT THE ATTENDING PHYSICIAN SHOULD BE INFORMED OF PT RECEIVING UNTREATED CELLS. CUSTOMER WAS INFORMED THAT PT SHOULD BE INSTRUCTED TO BE FULLY PROTECTED FROM THE SUN. SERVICE ORDER: (B)(4) WAS DISPATCHED. PRODUCT WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622128 THERAKOS XTS PHOTOPHERESIS SYSTEM XTS LNR THERAKOS, INC. C735 - KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 R.N.P