BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE INFUSION SET

    MDR report key: 4121914 · Received September 22, 2014

    Report

    Report Number
    MW5038356
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 22, 2014
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT RETURNED FROM U/S WHERE IV PUMP WAS BEEPING. PICC LINE SLUGGISH, BUT ABLE TO BE FLUSHED. OPENED IV CHANNEL ON PUMP AND FOUND APPROXIMATELY 1 INCH BULGE (SIMILAR TO AN ANEURYSM IN A PATIENT) AT THE TOP OF THE SOFT SECTION OF TUBING. TUBING CAPPED AND NEW TUBING HUNG ON PATIENT WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587513 SMARTSITE INFUSION SET PRIMARY IV TUBING FPA CAREFUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR