BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS XTS SYSTEM

    MDR report key: 4120921 · Received July 25, 2014

    Report

    Report Number
    2523595-2014-00193
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT B733 WAS CONDUCTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. TRENDS HAVE BEEN REVIEWED FOR THIS COMPLAINT CATEGORY AND NO TRENDS HAVE BEEN DETECTED FOR LEAK CENTRIFUGE ALARM. THE ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THE INVESTIGATION. THE PRODUCT HAS NOT YET BEEN RECEIVED FOR INVESTIGATION AT THE TIME OF THE REPORT; THEREFORE, FINAL INVESTIGATION FINDINGS ARE STILL PENDING. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT BLOOD LEAK ALARM DURING START OF TREATMENT PROCEDURE. CUSTOMER STATED THAT THE BLOOD HAD JUST GOTTEN TO THE TUBING LEADING TO THE CENTRIFUGE BOWL, BUT HAD NOT QUITE REACHED THE BOWL YET. CUSTOMER STATED SHE DID NOT SEE ANY BLOOD IN THE BOWL. CUSTOMER ABORTED THE KIT AND DID NOT RETURN ANY BLOOD/PRODUCTS TO PATIENT. CSS ASKED IF THERE WAS BLOOD IN THE CENTRIFUGE, CUSTOMER STATED SHE COULD NOT SEE ANY BLOOD IN THE CENTRIFUGE. CSS ASKED IF THE ROOM WAS HUMID, CUSTOMER STATED NO IT WAS NOT. CUSTOMER WILL BE RETURNING PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436872 THERAKOS XTS SYSTEM XTS LNR THERAKOS, INC. B733-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR