BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRONIC INFUSION DEVICE

    MDR report key: 21614 · Received April 4, 1995

    Report

    Report Number
    MW4000677
    Event Type
    Injury
    Date Received
    April 4, 1995
    Report Date
    March 21, 1995
    Manufacturer
    UNKNOWN
    Product Code
    LZG
    Report Source
    Voluntary report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT STARTED ON IV DRIP OF INSULIN VIA ELECTRONIC INFUSION DEVICE (EID) IN THE EMERGENCY ROOM. PT TRANSPORTED TO HOSP ROOM BY A NON-PROFESSIONAL ESCORT. AFTER BEING PLACED IN BED, THE ESCORT REMOVED TUBING FROM THE EID WITHOUT CLAMPING IT, SO HE/SHE COULD RETURN THE EID TO THE ER. AS A RESULT A FREE-FLOW INFUSION OF INSULIN OCCURRED. RN NOTICED PT HAD SYMPTOMS OF HYPOGLYCEMIA AND STOPPED THE IV AND BEGAN DEXTROSE 5% INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRONIC INFUSION DEVICE ELECTRONIC INFUSION DEVICE LZG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention