BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD SECONDARY SET WITH CONV PIN

    MDR report key: 1071353 · Received July 8, 2008

    Report

    Report Number
    9613251-2008-00245
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 10, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K933326
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED NO FLOW. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION VIA AN UNSPECIFIED INFUSION PUMP. THE SECONDARY TUBING SET WAS BEING USED FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED CONCENTRATION OF ANCEF AND WAS CONNECTED TO THE PRIMARY TUBING SET. AFTER ONE HOUR IN USE, THE NURSE RETURNED TO THE PT'S ROOM AND NOTED THAT THE ANCEF HAD NOT DELIVERED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD SECONDARY SET WITH CONV PIN 80-FPA FPA HOSPIRA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED COLLEAGUE INFUSION PUMP| UNSPECIFIED PRIMARY CLEARLINK TUBING SET| MANUFACTURED BY BAXTER INTERNATIONAL INC.| MANUFACTURED BY BAXTER INTERNATIONAL INC.