BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER INTERNATIONAL INC.

    MDR report key: 741812 · Received July 10, 2006

    Report

    Report Number
    741812
    Event Type
    Injury
    Date Received
    July 10, 2006
    Date of Event
    June 5, 2006
    Report Date
    June 13, 2006
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    4 GM MSO4 PROGRAMMED INTO IV PUMP CHAMBER "C" AT 100CC/HR. PT DEVELOPED SUDDEN AND SEVERE HYPOTENSION. IT WAS NOTED THAT ENTIRE BAG OF MGSO4 HAD BEEN BOLUSED IN LESS THAN 5 MIN. IV PUMP CONTINUED TO READ THAT IT WAS RUNNING AT 100CC/HR. PT REQUIRED THE ADMINISTRATION OF DOPAMINE AND 1000CC IV FLUID BOLUS. BP RECOVERED WITHIN 30 MINUTES WITHOUT RESIDUAL EFFECT. THIS UNIT WAS A RENTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER INTERNATIONAL INC. IV PUMP FRN BAXTER INTERNATIONAL INC. COLLEAGUE 3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention