BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD SECONDARY SET WITH CONV PIN

    MDR report key: 1061814 · Received June 13, 2008

    Report

    Report Number
    9613251-2008-00181
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 1, 2008
    Report Date
    June 9, 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

    A DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF NO FLOW. THE SECONDARY TUBING SETS WERE CONNECTED TO UNSPECIFIED PRIMARY TUBING SETS AND WERE BEING USED FOR PIGGYBACK DELIVERIES OF AN UNSPECIFIED CONCENTRATION OF PITOCIN VIA UNSPECIFIED PUMP. THE HEIGHTS OF THE SOLUTION CONTAINERS WERE NOT SPECIFIED. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE NURSES NOTED THE PITOCIN WAS NOT DELIVERING. THE TUBING SETS WERE REPLACED THE THERAPIES WERE RESUMED. 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 LIFESHIELD SECONDARY SET WITH CONV PIN 80-FPA FPA HOSPIRA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED TUBING SETS| UNSPECIFIED INFUSION PUMPS