BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 1843493 · Received September 2, 2010

    Report

    Report Number
    1843493
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 2, 2010
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    INTRALIPID TUBING FOUND ON FLOOR BESIDE PATIENT BEDSIDE. TUBING DISCONNECTED SPONTANEOUSLY, STAFF DID NOT STATE EXACTLY WHERE DISCONNECTED BUT LOOKING AT TUBING LOOKS LIKE TUBING DISCONNECTED FROM NEEDLE FREE VALVE PORT, NEEDLE FREE VALVE PORT NOT INCLUDED IN THIS TUBING THAT WAS SAVED.IS EVENT HEALTH IT RELATED?NODEVICE #1IS DEVICE INVOLVED IN HIT ISSUENO

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 7 WK