BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX SYSTEM

    MDR report key: 4092755 · Received September 10, 2014

    Report

    Report Number
    2523595-2014-00189
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT B348 WAS CONDUCTED. THERE WERE NO NONCONFORMANCES RELATED TO THE NATURE OF THIS COMPLAINT. THIS LOT MET RELEASE REQUIREMENTS. TRENDS WERE REVIEWED FOR THIS COMPLAINT CATEGORY AND NO TRENDS WERE DETECTED. HOWEVER, CAPA'S (B)(4) HAVE ALREADY BEEN INITIATED TO FURTHER INVESTIGATE PRESSURE DOME MEMBRANE LEAKS. 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.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT SYSTEM PRESSURE DOME LEAK WHEN REMOVING THE KIT FROM THE INSTRUMENT. CUSTOMER STATED SHE WAS TURNING BLOOD PUMP AND ACCIDENTALLY TOOK OFF THE SYSTEM PRESSURE DOME. CSS ASKED CUSTOMER IF PATIENT WAS CONNECTED TO THE INSTRUMENT. CUSTOMER STATED PATIENT TREATMENT WAS COMPLETED, SHE WAS REMOVING THE KIT FROM THE INSTRUMENT. CSS ASKED IF ANYONE WAS EXPOSED TO BLOOD/FLUIDS, CUSTOMER STATED NO, NO ONE WAS EXPOSED TO BLOOD/FLUID FROM THE LEAK. CSS ASKED PRESSURE TRANSDUCER WAS CLEANED OR SERVICE WAS NEEDED. CUSTOMER STATED SHE HAS CLEANED UP THE BLOOD AND SERVICE IS NOT REQUIRED. CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556832 THERAKOS CELLEX SYSTEM CELLEX LNR THERAKOS, INC. B348-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1