BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER FLO-GARD 6301

    MDR report key: 222681 · Received May 5, 1999

    Report

    Report Number
    222681
    Event Type
    Injury
    Date Received
    May 5, 1999
    Date of Event
    April 27, 1999
    Report Date
    April 28, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    04/27/99 2000 STARTED 0.9 SODIUM CHLORIDE 250ML WITH 250 UNITS OF NOVOLIN (HUNAN) REGULAR INSULIN. 1:1 CONCENTRATION RATE 4ML/HR. 2100 NURSE ENTERED ROOM AND APPROX 150ML HAD INFUSED. PUMP TURNED OFF. BLOOD SUGAR CHECKED = 73 IMMEDIATELY AFTER DISCOVERY. LOWEST BLOOD SUGAR WAS 53. NOTE: SIDE II WAS BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER FLO-GARD 6301 DUAL CHANNEL VOLUMETRIC INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 6301 *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention