BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 1843497 · Received September 3, 2010

    Report

    Report Number
    1843497
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    July 27, 2010
    Report Date
    September 3, 2010
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 500ML NORAML SALINE (NS) BOLUS WAS HUNG AS A SECONDARY TO RUN AT A RATE OF 999ML/HR. AFTER LOOKING AT THE DRIPS AND PUMP SHORTLY AFTER STARTING IT, THE FLUID WAS BEING PULLED FROM THE PRIMARY (IT WAS EMPTY) AND NOT FROM THE SECONDARY. THE SECONDARY WAS HANGING HIGHER THAN THE PRIMARY, AND THE ROLLER CLAMP WAS OPEN. THE SECONDARY TUBING WAS CHANGED BUT THE SAME THING OCCURRED. THE PRIMARY AND SECONDARY TUBING WAS CHANGED AND THEN THE FLUIDS RAN APPROPRIATELY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DEFECTIVE PRIMARY TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS IV TUBING FPA CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR