BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX SYSTEM

    MDR report key: 3830773 · Received May 9, 2014

    Report

    Report Number
    2523595-2014-00138
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT C104 WAS CONDUCTED. THERE WERE NO NON CONFORMANCES FOR THIS LOT. LOT MET RELEASE REQUIREMENTS. TRENDS HAVE BEEN REVIEWED FOR THIS COMPLAINT CATEGORY AND NO TREND HAS BEEN DETECTED. CAPA# (B)(4) ARE ALREADY OPENED TO INVESTIGATE CELLEX PRESSURE DOME MEMBRANES AND LEAKS. THE ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION BY THE CUSTOMER. THEREFORE, IT CAN NOT BE DETERMINED IF THIS PARTICULAR PRODUCT MET SPECIFICATIONS. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. SHOULD A TREND ARISE, FURTHER ACTION WILL BE TAKEN AS DEEMED APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED BLOOD LEAK AT THE LEVEL OF THE SYSTEM PRESSURE DOME AT 250 ML OF WHOLE BLOOD PROCESSED. CUSTOMER REPORTS THE SYSTEM PRESSURE DOME MEMBRANE SEEMS MISPLACED AFTER INSPECTION. TREATMENT ABORTED, NO BLOOD RETURNED TO PT. DURING PRIME, CUSTOMER REPORTED TO HAVE HAD A COLLECT PUMP ERROR WHICH THEY SOLVED BY REINSTALLING THE TUBES AROUND THE SAME PUMP. THE PRESSURE DOMES WERE NOT CONTROLLED DURING THIS OPERATION. PT IS STABLE. NEW TREATMENT DONE ON ANOTHER MACHINE. BLOOD GOT IN THE COLLECT PUMP WHICH WAS UNMOUNTED AND CLEANED. NO PRODUCT WILL BE RETURNED BY THE CUSTOMER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281111 THERAKOS CELLEX SYSTEM CELLEX LNR THERAKOS INC. C104-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1