BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECONDARY OMNI FLOW SET 40

    MDR report key: 1181975 · Received September 22, 2008

    Report

    Report Number
    9613251-2008-00343
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 25, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K832755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED NO FLOW. THE SECONDARY TUBING SET WAS BEING USED FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED ANTIBIOTIC. THE CUSTOMER CONTACT REPORTED THE SECONDARY SOLUTION DID NOT FLOW AFTER THE SECONDARY TUBING SET WAS CONNECTED TO THE DISTAL Y-SITE OF THE PRIMARY TUBING SET. IT WAS REPORTED THAT THE PRIMARY DELIVERY WAS "STOPPED" AND THE SECONDARY DELIVERY WAS COMPLETED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECONDARY OMNI FLOW SET 40 80-FPA FPA HOSPIRA LTD. NA 630144W

    Patients

    Seq Age Sex Outcome Treatment
    1 MANUFACTURED BY BAXTER INTERNATIONAL| PRIMARY TUBING SET