BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI PC-1

    MDR report key: 223997 · Received May 14, 1999

    Report

    Report Number
    2016493-1999-00075
    Event Type
    Malfunction
    Date Received
    May 14, 1999
    Date of Event
    April 11, 1999
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    Removal / Correction Number
    Z247-8/Z248-8
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A 250 ML BAG OF MAGNESIUM WAS HUNG AND THE PUMP WAS SET UP TO INFUSE MAGNESIUM SULFATE AT A RATE OF 2 G/HR. THE VTBI WAS SET AT 202ML. NURSE STATED THAT THE PUMP INFUSED 200 ML BETWEEN 9:50 AM AND 11:30 AM. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI PC-1 INFUSION PUMP/CONTROLLER FRN ALARIS MEDICAL SYSTEMS, INC. 1310 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN