BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 1833417 · Received August 20, 2010

    Report

    Report Number
    1833417
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 20, 2010
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE IV TUBING SET WAS RUN THROUGH WITH DEXTROSE 10% AND PLACED IN THE ALARIS PUMP AND WAS INFUSING THROUGH A PERIPHERAL INTRAVENOUS LINE (PIV) INTO THE BABY. THE RN STANDING AT BEDSIDE DOING CARE ON THE PATIENT HEARD AND SAW A LARGE AMOUNT OF FLUID DROP ONTO THE FLOOR. THE RN NOTED THE BURETROL HAD GIVEN WAY FROM THE BASE COMPLETELY AND ALL THE FLUID HAD FALLEN ONTO THE FLOOR, WALL AND BEDSIDE EQUIPMENT. THE WHITE ENDCAP AT THE BASE OF THE CYLINDER OF THE BURETTE HAD POPPED OFF. THE FLUID WAS IMMEDIATELY STOPPED AND NEW IV FLUID WAS RUN THRU WITH A NEW TUBING SET WITHOUT ISSUE AND PATIENT RESTARTED INTO THE PIV.====================== HEALTH PROFESSIONAL'S IMPRESSION======================BOTTOM CAP OF THE BURETTE SHOULD NOT HAVE POPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS IV PUMP SET, BURETTE, 4-PORT PEDI FPA CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA