BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 1870420 · Received September 28, 2010

    Report

    Report Number
    1870420
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 18, 2010
    Report Date
    September 28, 2010
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT DOSE OF MAGNESIUM SULFATE 4G IV PIGGY BACK X 1 HUNG AT 12:30. BAG CONNECTED WITH LUERLOCK PRONG TO PORT ABOVE PUMP LEVEL. PRIMARY BAG WAS NORMAL SALINE AT 75CC/HOUR. PUMP SET TO RUN DOSE OVER 4 HOURS AT 25 CC/HR FOR 100CC BAG. AT 30 MINUTES LATER, MAGNESIUM BAG WAS DRY. PATIENT NEUROLOGICAL STATUS AT BASELINE. VITALS: HR 50, BP 162/86, O2 SATURATION 94% ON RIGHT ATRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM INFUSION PUMP FRN SIGMA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *