BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKO UVAR XTS PHOTO PHERESIS SYSTEM

    MDR report key: 3834599 · Received March 19, 2014

    Report

    Report Number
    2523595-2014-00084
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 21, 2014
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT B730 WAS PERFORMED. THERE WERE NO NONCONFORMANCES. THIS LOT MET ALL RELEASE REQUIREMENTS. TRENDS HAVE BEEN REVIEWED FOR THIS COMPLAINT CATEGORY AND NO TREND HAS BEEN DETECTED. THIS ASSESSMENT IS BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. THE CUSTOMER RETURNED THE KIT FOR INVESTIGATION. HOWEVER, THE ROOT CAUSE CANNOT YET BE DETERMINED AS THE INVESTIGATION IS STILL ONGOING. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER IS REPORTING AN FLM LEAK. NAME AND FUNCTION OF COMPLAINANT: SAME AS REPORTER. CUSTOMER CALLED TO REPORT BLOOD LEAKED WHEN REMOVING FLM AFTER TREATMENT PROCEDURE WAS COMPLETED. CSS ASKED CUSTOMER IF THERE WERE ANY ALARMS DURING PRIME OR DURING THE PROCEDURE. CUSTOMER STATED THERE WERE NO ALARMS. CSS ASKED IF PT WAS ALRIGHT, CUSTOMER STATED YES PT IS STABLE AND HAS BEEN DISCHARGED. CSS ASKED IF SERVICE WOULD BE REQUIRED. CUSTOMER STATED SERVICE IS NOT REQUIRED. CUSTOMER WILL NOT RETURN PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163387 THERAKO UVAR XTS PHOTO PHERESIS SYSTEM UVAR XTS ECP SYSTEM LNR THERAKOS INC. 6660 B730-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR