BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS GEMINI PC-IT

    MDR report key: 1030117 · Received April 15, 2008

    Report

    Report Number
    2016493-2008-00026
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 17, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K88393
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    CUSTOMER REPORTS OVERINFUSION OF NAFCILLIN. STATES THE INFUSION DOSE WAS NAFCILLIN 10 GRAMS IN 1000 ML DILUENT TO INFUSE AT 42 ML PER HOUR. REPORTS AFTER 500 ML OF THE 1000 ML HAD INFUSED, CHANGED THE TUBING DUE TO MULTIPLE AIR-IN-LINE ALARMS. ONE HOUR AFTER RESTARTING THE INFUSION, THE DEVICE ALARMED AND THE IV BAG WAS EMPTY, THE REMAINING 500 ML HAD INFUSED. THE PT WAS MONITORED FOR FLUID OVERLOAD SYMPTOMS OF RESPIRATORY DISTRESS. NO MEDICAL INTERVENTION REQUIRED OR ILL EFFECTS EXPERIENCED BY THE PT. INVESTIGATION: THE 1310BR MODEL HAS NO VALID EVENT HISTORY LOG THEREFORE THE EVENTS SURROUNDING THE INCIDENT COULD NOT BE DETERMINED. DATA FROM THE ERROR LOG WAS EMPTY AND THE INFUSION PARAMETERS HAD BEEN CLEARED. RATE ACCURACY TESTING AD 42 ML/HOUR YIELDED A MEAN FLOW RATE OF 41.74 ML/HR. THE REPORTED EVENT OF OVERINFUSION COULD NOT BE CONFIRMED. TESTING AND INSPECTION FOUND THE DEVICE TO BE IN GOOD WORKING CONDITION AND DELIVERING FLUID WITHIN SPECS AT THE INCIDENT INFUSION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS GEMINI PC-IT FRN INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 1310BR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention