BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD SECONDARY SET WITH CONV PIN

    MDR report key: 1061817 · Received June 13, 2008

    Report

    Report Number
    9613251-2008-00179
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K933326
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CONCURRENT FLOW. THE SECONDARY TUBING SET WAS CONNECTED TO A PRIMARY TUBING SET AND WAS BEING USED FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED CONCENTRATION OF MAGNESIUM SULFATE VIA AN UNSPECIFIED PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE RETURNED TO THE PATIENT'S ROOM EXPECTING DELIVERY OF THE PIGGYBACK TO BE COMPLETE; HOWEVER, BOTH THE SECONDARY AND PRIMARY SOLUTIONS WAS DELIVERING. THE NURSE INCREASED THE HEIGHT OF THE SECONDARY SOLUTION CONTAINER AND THE PRIMARY SOLUTION CONTAINER CONTINUED TO DELIVER. THE SECONDARY TUBING SET WAS REPLACED AND THE PIGGYBACK DELIVERY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 UNK UNSPECIFIED INFUSION PUMP| UNSPECIFIED PRIMARY TUBING SET MFG BY BAXTER INT'L