BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX SYSTEM

    MDR report key: 3983390 · Received July 7, 2014

    Report

    Report Number
    2523595-2014-00182
    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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT C316 WAS CONDUCTED AND 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 TREND WERE DETECTED. HOWEVER, CAPA'S (B)(4) WERE INITIATED TO FURTHER INVESTIGATE PRESSURE DOME ISSUES. 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 PRESSURE DOME LEAK DURING THE RETURN PHASE OF THE TREATMENT PROCEDURE. THE CENTRIFUGE HAD STOPPED DURING THE RETURN PHASE OF THE PROCEDURE WHEN THE COLLECT PRESSURE DOME CAME OFF AND BLOOD LEAKED ONTO THE INSTRUMENT. THE INSTRUMENT WAS OPERATING IN SINGLE NEEDLE MODE WITH VORTEX PORT ACCESS. A 690 ML WHOLE BLOOD PROCESSED. CUSTOMER REPORTED THAT NO ONE WAS EXPOSED TO BLOOD OR BODY FLUIDS WHEN THE LEAK OCCURRED. THE TREATMENT WAS ABORTED WITH NO RETURN OF BLOOD TO THE PT. CUSTOMER STATED THERE WERE A FEW RETURN PRESSURE ALARMS DURING THE TREATMENT, WHICH WERE CLEARED BY FLUSHING THE LINE TO CONTINUE WITH THE RETURN PHASE. CUSTOMER STATED THERE WERE NO OCCLUSIONS OR CLOTTING THROUGHOUT THE KIT. PT WAS REPORTED TO BE IN STABLE CONDITION. NO PRODUCT WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395091 THERAKOS CELLEX SYSTEM CELLEX LNR THERAKOS, INC. C316 - KIT

    Patients

    Seq Age Sex Outcome Treatment
    1