BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 2250904 · Received August 29, 2011

    Report

    Report Number
    2250904
    Event Type
    Malfunction
    Date Received
    August 29, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 29, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    MOM CALLED RN INTO THE ROOM AS PATIENT TPN/LIPIDS TUBING HAD BECOME DISCONNECTED AND WAS LAYING BESIDE PATIENT. PUMPS STOPPED AND SURGEON NOTIFIED. LIPIDS REORDERED AND IV FLUIDS ORDERED UNTIL TPN COMES UP TONIGHT. DISCONNECTED AT MALE ADAPTER OF Y CONNECTOR TO NEEDLE FREE VALVE. FOLLOW-UP WITH STAFF TO ENSURE CONNECTIONS ARE TIGHT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO