BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS XTS SYSTEM

    MDR report key: 3983404 · Received July 7, 2014

    Report

    Report Number
    2523595-2014-00181
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT C709 WAS CONDUCTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. TRENDS WERE REVIEWED FOR THIS COMPLAINT CATEGORIES INVOLVED IN THIS COMPLAINT AND NO TRENDS WERE DETECTED. THE ASSESSMENT IS BASED ON INFO 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 INFO PROVIDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BLOOD PUMP ERROR ALARM OCCURRED AT THE END OF FIRST CYCLE. CUSTOMER OBSERVED AIR GOING FROM FLM TO THE RETURN BAG. THE RETURN BAG WAS INFLATED. THE CUSTOMER TRIED TO GIVE A SALINE BOLUS TO FLUSH THE FLM. SALINE EMPTY ALARM OCCURRED. CUSTOMER COULD NOT RESET THE BLOOD PUMP ERROR ALARM AND DECIDE TO ABORT THE TREATMENT. THE CUSTOMER WANTED TO RETURN THE BLOOD TO THE PT BY MANUAL RETURN. WHEN CUSTOMER HAD MOVED THE WHOLE VOLUME TO THE TREATMENT BAG, THE CUSTOMER NOTICED A LEAK AT THE UPPER WELD OF THE TREATMENT BAG. CLINICAL SERVICES SPECIALIST INFORMED THE CUSTOMER THAT THE VOLUME IN THE KIT SHOULD NOT BE RETURNED TO THE PT BECAUSE IN CASE OF A LEAK, THE KIT COULD BE NON-STERILE. IT WAS REPORTED THAT THE PT WAS IN STABLE CONDITION AND HAD RECEIVED 250 ML SALINE INFUSION. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394910 THERAKOS XTS SYSTEM XTS LNR THERAKOS, INC. C709 - KIT

    Patients

    Seq Age Sex Outcome Treatment
    1