BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI PC-2

    MDR report key: 1051499 · Received May 12, 2008

    Report

    Report Number
    1051499
    Event Type
    Malfunction
    Date Received
    May 12, 2008
    Date of Event
    April 18, 2007
    Report Date
    May 2, 2008
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A POSSIBLE UNDER-INFUSION OF 100 ML OF CHEMOTHERAPY SOLUTION. AFTER THE PUMP ALARMED THAT THE INFUSION WAS COMPLETE, THE NURSE NOTICED THAT THERE WAS STILL FLUID LEFT IN THE BAG. THERE WERE NO LEAKS REPORTED AT ANY SITE ON THE IV LINE. CONSIDERING THE ACCURACY OF CH B OF + 7%, AND THE INFUSION DURATION TIME, BIOMED CALCULATED THAT THE PATIENT RECEIVED 111 ML OF THE DRUG. THIS AMOUNT, ALONG WITH THE REMAINING 19 ML VTBI, SHOWED THAT THE PUMP WAS SET TO CONTINUE THE INFUSION, BUT WAS INTERRUPTED, AS DEMONSTRATED BY THE AMOUNT OF IV FLUID LEFT IN THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI PC-2 PUMP, IV FRN ALARIS MEDICAL SYSTEMS, INC. 1325D *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR