BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SMARTSITE

    MDR report key: 2771640 · Received August 29, 2012

    Report

    Report Number
    2771640
    Event Type
    Malfunction
    Date Received
    August 29, 2012
    Date of Event
    August 13, 2012
    Report Date
    August 29, 2012
    Manufacturer
    CAREFUSION 303, INC.
    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

    PRIMED PUMP WITH PROPOFOL, INSERTED INTO PUMP, PROGRAMMED PUMP AND CONNECTED TO PATIENT. THE PUMP KEPT ALARMING "OCCLUDED PATIENT SIDE". WHEN TUBING WAS DISCONNECTED FROM PUMP, THERE WAS A LARGE BULGE IN THE TUBING IN THE SECTION THAT GOES THROUGH THE PUMP HOUSING. THE TUBING WAS CHANGED AND THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR