BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 1833443 · Received August 23, 2010

    Report

    Report Number
    1833443
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    August 14, 2010
    Report Date
    August 23, 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

    PUMP BEEPING DOOR OPEN. DOOR OPENED AND INTRAVENOUS LIPID (IL) TUBING POPPED OUT. LARGE BUBBLE NOTED IN TUBING THAT WAS IN PUMP CHAMBER. IV TUBING SAVED. PICC LINE FLUSHED EASILY, NEW IL OBTAINED AND HUNG. PUMP WAS NOT TESTED. RNS DID NOT THINK IT WAS PUMP RELATED.

    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 2 WK