BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE SPECTRA LRS TURBO VERSION 7.0

    MDR report key: 556862 · Received October 5, 2004

    Report

    Report Number
    MW1033412
    Event Type
    Malfunction
    Date Received
    October 5, 2004
    Date of Event
    September 10, 2004
    Report Date
    October 5, 2004
    Manufacturer
    GAMBRO BCT, INC.
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    APHERESIS PLATELET COLLECTION WAS BEING PERFORMED ON A DONOR USING COBE SPECTRA, VERSION 7.0 LRS TURBO. PER INSTITUTIONAL PROTOCOL THE OPERATOR PERFORMED FLOW RATE, VOLUME AND COLLECT CONCENTRATION MONITOR -CCMO CHECKS AT 15 AND 33 MINUTES. AT 33 MINUTES THE OPERATOR NOTED THE CCM READING TO BE ONLY 0.1 -X 10E11 PLATELETS- FOR THIS COLLECTION. AT 35 MINUTES AN ALARM OCCURRED INDICATING THAT THE CCM HAD NOT DETECTED PLATELETS. A TWISTED ANTICOAGULANT LINE WAS DETECTED WHICH WAS DELIVERING INSUFFICIENT AMOUNTS OF ACD-A INTO THE SYSTEM. THE PROCEDURE WAS TERMINATED. LARGE AMOUNTS OF FIBRIN WERE NOTED IN THE COLLECTION BAG, THE CLOTTED PRODUCTS WERE DISCARDED. THE DONOR WAS CONTACTED THE FOLLOWING DAY FOR ASSESSMENT, THEY EXHIBITED NO ADVERSE EFFECTS FROM THE PROCEDURE. GAMBRO WAS CONTACTED TO REPORT THE CONCERN THAT THERE IS NO ALARM TO ALERT THE OPERATOR THAT INSUFFICIENT AMOUNT OF ANTICOAGULANT WAS BEING DELIVERED INTO THE SYSTEM. RPTR WAS TOLD THAT THE CO IS AWARE THAT THIS CAN OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA LRS TURBO VERSION 7.0 APHERESIS SYSTEM GKT GAMBRO BCT, INC. SPECTRA LRS TURBO VER DISPOSABLES - 03K002

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other