BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS/MEDLEY

    MDR report key: 2222059 · Received August 18, 2011

    Report

    Report Number
    MW5021826
    Event Type
    Other
    Date Received
    August 18, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 18, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    SMARTSITE INFUSION SET (B)(4) ALARIS/CAREFUSION TUBING LEAKED AT JUNCTURE OF BLUE CONNECTOR AND SOFT SECTION OF TUBING. IV FLUIDS INFUSING AT THE TIME OF LEAKAGE WAS NORMAL SALINE 1000ML WITH 20 MEQ POTASSIUM CHLORIDE AND 2 G MAGNESIUM SULFATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS/MEDLEY SMARTSITE INFUSION SET FPA CAREFUSION H370242000071

    Patients

    Seq Age Sex Outcome Treatment
    1