BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS

    MDR report key: 267812 · Received February 28, 2000

    Report

    Report Number
    MW1018346
    Event Type
    Injury
    Date Received
    February 28, 2000
    Date of Event
    January 3, 2000
    Report Date
    February 11, 2000
    Manufacturer
    FRESENIUS USA, INC.
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DIALYSIS RN USING CONTINUOUS ARTERIO-VENOUS HEMOFILTRATION SYSTEM UNAWARE THAT ULTRAFILTRATION DEFAULTS TO 200 CC/HR W/PLUGGING AND CONNECTION. CAUSED ULTRAFILTRATION OFF AT ACCELERATED RATE. PT HYPOTENSIVE. DISCONTINUED TREATMENT. ALBUMIN ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYSIS FII FRESENIUS USA, INC. 2008H *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DAY Required Intervention