BEUDAMED
    FDA Adverse Event Summary report: N

    SMARTSITE INFUSION SET AND 15 DROP ADMIN SET

    MDR report key: 1531542 · Received November 9, 2009

    Report

    Report Number
    1531542
    Date Received
    November 9, 2009
    Date of Event
    October 15, 2009
    Report Date
    November 9, 2009
    Manufacturer
    CAREFUSION HEALTHCARE CARDINAL HEALTH
    Product Code
    FPA
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    MAGNESIUM IV WAS HUNG AS SECONDARY INFUSION AT 50 ML'S PER HOUR. SECONDARY TUBING CLAMP WAS OPENED THE ENTIRE MEDICATION RAN INTO THE PRIMARY BAG. IV PUMP STILL WAS RUNNING AT 50 ML'S PER HOUR. THE IV TUBING SETS AND IV BAGS WERE REMOVED AND TAKEN TO RISK MANAGEMENT. THE PATIENT WAS NOT HARMED.

    Description of Event or Problem · 1

    MAGNESIUM IV WAS HUNG AS SECONDARY INFUSION AT 50 ML'S PER HOUR. SECONDARY TUBING CLAMP WAS OPENED THE ENTIRE MEDICATION RAN INTO THE PRIMARY BAG. IV PUMP STILL WAS RUNNING AT 50 ML'S PER HOUR. THE IV TUBING SETS AND IV BAGS WERE REMOVED AND TAKEN TO RISK MANAGEMENT. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE INFUSION SET AND 15 DROP ADMIN SET IV TUBING FPA CAREFUSION HEALTHCARE CARDINAL HEALTH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR NO OTHER THERAPIES| NO OTHER THERAPIES