BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX SYSTEM

    MDR report key: 3983409 · Received July 7, 2014

    Report

    Report Number
    2523595-2014-00185
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    THERAKOS INC
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW LOT C108 WAS CONDUCTED. THERE WERE NO NONCONFORMANCE RELATED TO THE NATURE OF THIS COMPLAINT. THIS LOT MET RELEASE REQUIREMENTS. TRENDS WERE REVIEWED FOR THIS COMPLAINT CATEGORIES INVOLVED IN THIS COMPLAINT AND NO TRENDS WERE DETECTED. HOWEVER, CAPA (B)(4) WAS INITIATED TO FURTHER INVESTIGATE DRIVE TUBE LEAKS/BREAKS. SERVICE ORDER (B)(4) COMPLETED: SERVICE ENGINEER PERFORMED COMPLETE CHECKOUT, AND SYSTEM WORKING AS EXPECTED. EXTENDED TEST OF CENTRIFUGE AT DIFFERENT SPEEDS GAVE NO ERRORS OR VIBRATION; CHECKED AND TIGHTENED MONITOR MOUNT TO MINIMIZE ANY VIBRATION. SYSTEM RETURNED TO CUSTOMER AS FIT FOR USE. THE ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT HAS YET BEEN 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 LEAK IN THE CENTRIFUGE CHAMBER AT 1084 ML OF WHOLE BLOOD PROCESSED. A HOLE WAS OBSERVED IN THE DRIVE TUBE. TREATMENT WAS ABORTED, NO BLOOD WAS RETURNED TO THE PT. PT WAS REPORTED IN STABLE CONDITION. SERVICE ORDER (B)(4) WAS DISPATCHED. CUSTOMER WILL RETURN PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395173 THERAKOS CELLEX SYSTEM CELLEX LNR THERAKOS INC C108 - KIT

    Patients

    Seq Age Sex Outcome Treatment
    1