BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS SMART SITE INFUSION SET

    MDR report key: 2211496 · Received August 9, 2011

    Report

    Report Number
    MW5021715
    Event Type
    Other
    Date Received
    August 9, 2011
    Date of Event
    July 24, 2011
    Report Date
    August 8, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN HUNG MEDICATION AT 100ML/HR. RN NOTED THAT THE RATE WAS TOO FAST AND NOTED FLUID COMING FROM THE IV PUMP. RN OPENED PUMP AND DISCONNECTED TUBING. AT THAT TIME, THE RN NOTED A SMALL HOLE IN THE TUBING. EQUIPMENT WAS REMOVED AND SENT TO CLINICAL ENGINEERING. NO HARM CAME TO THE PT. ISSUE WAS IDENTIFIED IMMEDIATELY AND TUBING WAS CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SMART SITE INFUSION SET IV INFUSION SET FPA CAREFUSION 11055289

    Patients

    Seq Age Sex Outcome Treatment
    1 Other