BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX SYSTEM

    MDR report key: 3851772 · Received April 22, 2014

    Report

    Report Number
    2523595-2014-00103
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 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

    BATCH RECORD REVIEW OF LOT B352 WAS CONDUCTED. THERE WERE NO NON CONFORMANCES ASSOCIATED WITH THIS LOT. LOT MET RELEASE REQUIREMENTS. TRENDS HAVE BEEN REVIEWED FOR THIS COMPLAINT CATEGORY AND NO TREND HAS BEEN DETECTED; HOWEVER THERE ARE CURRENTLY TWO CAPAS (CAPA (B)(4)) OPENED TO INVESTIGATE PRESSURE DOME MEMBRANE LEAK FAILURES. SERVICE ORDER (B)(4) COMPLETED: SERVICE ENGINEER CLEANED UP BLOOD SPILL FROM PUMP DECK AND CENTRIFUGE CHAMBER; REPLACED AND CALIBRATED COLLECT AND RETURN PRESSURE TRANSDUCERS. RAN SYSTEM CHECKOUT PROCEDURE. ALL WORK COMPLETED AS PER SERVICE DOCUMENTATION. THE ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED BY THE CUSTOMER FOR INVESTIGATION; THEREFORE, THE ROOT CAUSE FOR THE LEAK CANNOT BE DETERMINED BASED SOLELY ON THE INFO PROVIDED BY THE CUSTOMER. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF ADDITIONAL INFO IS RECEIVED, COMPLAINT WILL BE REOPEN AND PROCESSED ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT AIR IN THE RETURN CHAMBER. CUSTOMER STATED AFTER PROCESSING 500ML, THE RETURN BAG WAS EMPTY AND AIR WAS BEING PULLED FROM THE BAG INTO THE RETURN CHAMBER. CSS ASKED IF THERE WERE ANY ALARMS DURING PRIME, OR IF IT WAS POSSIBLE THE BAG WAS NOT TARED PROPERLY DUE TO FALLING OFF THE SCALE OR THE SCALE BEING INTERFERED WITH. CUSTOMER DENIED ANY PROBLEMS WITH PRIME. CSS ASKED IF THE BAGS WERE TARED AND ZEROED OUT AFTER PRIME. CUSTOMER STATED THEY WERE. CUSTOMER STATED SHE WAS IN SINGLE NEEDLE MODE AND CHANGED TO DOUBLE NEEDLE MODE TO SEE IF THAT WOULD HELP. IT DID NOT. CSS ADVISED SHE WOULD NEED TO ABORT THE TREATMENT. CSS INFORMED THE CUSTOMER HOW TO PROCEED WITH A MANUAL RETURN IF SHE DECIDED TO DO SO. CUSTOMER CHOSE NOT TO RETURN THE CELLS BECAUSE THE PT WAS STABLE. UPON REMOVING THE KIT, CUSTOMER STATES THE COLLECT PRESSURE DOME MEMBRANE 'EXPLODED' OFF OF THE DOME AND CAUSED A BLOOD LEAK ALL OVER THE PUMP DECK. CUSTOMER IS REQUESTING SERVICE DUE TO BLOOD GETTING INTO THE COLLECT AND RETURN PRESSURE TRANSDUCERS. SERVICE ORDER (B)(4) WAS DISPATCHED TO SERVICE THE INSTRUMENT. UPDATED ON (B)(4) 2014 (B)(6) CUSTOMER CALLED BACK TO GIVE REQUESTED PT DATA. PT REPORTED TO FEEL DIZZY AND LIGHTHEADED; 1 RED BLOOD CELL UNIT TRANSFUSED. NO PRODUCT WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243745 THERAKOS CELLEX SYSTEM CELLEX LNR THERAKOS, INC. B352 -KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention