BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ FLOW

    MDR report key: 19001 · Received January 17, 1995

    Report

    Report Number
    MW1004778
    Event Type
    Injury
    Date Received
    January 17, 1995
    Date of Event
    January 9, 1995
    Report Date
    January 10, 1995
    Manufacturer
    CREATIVE MEDICAL DEVELOPEMENT, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    AN IV BAG CONTAINING NAFCILLIN 12 GRAMS IN 300 ML OF NORMAL SALINE WAS PREPARED AND ATTACHED TO AN INFUSION PUMP. THE PUMP WAS PROGRAMMED TO DELIVER 50 ML OF THE PREPARATION OVER 1 HOUR AND TO REPEAT THIS FUNCTION EVERY 4 HOURS FOR 24 HOURS. THE ENTIRE INFUSION WAS DELIVERED OVER A PERIOD OF LESS THAN 1 HOUR. PT CALLED AMBULATORY INFUSION CENTER TO REPORT EVENT AND COMPLAINED OF DIZZINESS. PHARMACIST AT CENTER CONSULTED REFERENCES FOR SPECIFIC OVERDOSE INSTRUCTIONS, AND FINDING NONE, CALLED REGIONAL POISON CONTROL CENTER. PT'S PHYSICIAN WAS NOTIFIED. PT WAS MONITORED AT HOME THE REMAINDER OF THE EVENING AND RETURNED TO THE INFUSION CENTER ON 1/10/95. THE PUMP AND TUBING WERE SENT TO THE MFR FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ FLOW AMBULATORY INFUSION PUMP FRN CREATIVE MEDICAL DEVELOPEMENT, INC. 80-2

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention