BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERILE WATER FOR INHALATION, USP

    MDR report key: 502356 · Received December 17, 2003

    Report

    Report Number
    6000001-2003-09423
    Event Type
    Injury
    Date Received
    December 17, 2003
    Date of Event
    December 1, 2003
    Report Date
    December 2, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY A MECHANICALLY VENTILATED, PATIENT WAS ADMINISTERED 300 ML OF STERILE WATER FOR INHALATION, USP INSTEAD OF THE INTENDED 5% DEXTROSE AND 0.45% SODIUM CHLORIDE INJECTION, USP. THE PATIENT DEVELOPED A TOTAL BODY RASH. AFTER A SHIFT CHANGE OCCURRED, THE ONCOMING NURSE RESPONDED TO THE PATIENT'S COMPLAINT OF A RASH AND NOTED THE MEDICATION ERROR. THE PATIENT WAS TREATED WITH AN UNSPECIFIED AMOUNT OF BENADRYL AND THE RASH RESOLVED. THE PATIENT WAS DISCHARGED WITHOUT PROLONGATION TO THIER HOSPITAL STAY. REPORTER STATED THAT THE PATIENT EXPERIENCED NO SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILE WATER FOR INHALATION, USP STERILE WATER FOR RESPIRATORY THERAPY CAF BAXTER HEALTHCARE CORP. NA C580340

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention