BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STREAMLINE

    MDR report key: 4120931 · Received September 8, 2014

    Report

    Report Number
    4120931
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Date of Event
    July 9, 2014
    Report Date
    September 8, 2014
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    UPON INITIATION OF DIALYSIS TREATMENT, NURSE NOTED BLOOD SPATTERS IN THE VENOUS MONITOR LINE. TREATMENT WAS STOPPED. BLOOD FROM VENOUS LINE NOT REINFUSED TO PATIENT DUE TO QUESTION OF CONTAMINATION OF LINE. BLOOD FROM ARTERIAL LINE REINFUSED. EBL 150ML. NEW SYSTEM SET UP AND PT RESTARTED ON DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551196 STREAMLINE SET, TUBING FJK B. BRAUN MEDICAL INC. * 40555142

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR