BEUDAMED
    FDA Adverse Event Other Summary report: N

    BURETOL ADD-ON SET

    MDR report key: 223059 · Received May 10, 1999

    Report

    Report Number
    6000001-1999-00262
    Event Type
    Other
    Date Received
    May 10, 1999
    Date of Event
    April 1, 1999
    Report Date
    April 27, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTS FOUR INCIDENTS IN WHICH AIR ENTERED AND MIGRATED DOWN THE TUBING, ALARMING THE AIR SENSOR WHICH IS DOWNSTREAM OF THE IMED PUMP. UTILIZED ON PEDIATRICS. RPTR STATED THE INCIDENTS OCCUR AT THE END OF THE INFUSION. RPTR ADDED THAT THERE WAS NO PT COMPROMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BURETOL ADD-ON SET BURETOL SET FPA BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN