BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER

    MDR report key: 11851 · Received February 15, 1994

    Report

    Report Number
    11851
    Event Type
    Malfunction
    Date Received
    February 15, 1994
    Date of Event
    January 7, 1994
    Report Date
    January 10, 1994
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 1100 IV OF D'S 1/4 NS STARTED WITH BLOOD RETURN ET RUNNING AT 50CC PER HOUR ON PATIENT AGE 9-1/2 MONTHS. AT 1400 ON ROUTINE SITE CHECK IV WAS NOTED TO BE GROSSLY INFILTRATED WITH PT'S KG BEING TAUNT ET BLANCHED FROM KNEE TO TOES. (INSERTION SITE WAS IN FOOT). OCLUSION ALARM NOT TRIGGERED AT ALL DURING THIS TIME FRAME ET IV CONTINUED PUMPING THOUGH INFILTRATED.PROBLEM: OCCLUSION ALARM INOPERATIVE OR NOT ALARMING AT CORRECT LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 6201

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO