BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONV. PN SEC MACRO LKN

    MDR report key: 628855 · Received August 19, 2005

    Report

    Report Number
    1713468-2005-00029
    Event Type
    Malfunction
    Date Received
    August 19, 2005
    Date of Event
    July 24, 2005
    Report Date
    July 27, 2005
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE CASSETTE INLET AND OUTLET TUBING SEGMENTS WERE REVERSED. IT WAS REPORTED THAT THE PHARMACY STAFF SPIKED THE TUBING SET INTO A SOLUTION CONTAINER CONTAINING TPN. THE SET-UP WAS SENT TO THE NURSING FLOOR WHERE THE TUBING SET WAS PRIMED MANUALLY AND THEN CONNECTED TO THE PATIENT'S CENTRAL LINE. THE CUSTOMER CONTACT REPORTED THAT AFTER THE TPN INFUSION WAS INITIATED AT AN UNSPECIFIED FLOW RATE, THE INFUSION PUMP STARTED IMMEDIATELY ALARMING FOR OCCLUSION. SUBSEQUENTLY, THE TUBING SET WAS NOTED TO HAVE THE CASSETTE INLET AND OUTLET TUBING SEGMENTS REVERSED. THE TUBING SET WAS DISCONNECTED FROM THE PATIENT. THE TPN INFUSION WAS RESUMED USING A REPLACEMENT TUBING SET. 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 CONV. PN SEC MACRO LKN ADMINISTRATION SET FPA HOSPIRA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other