BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHEILD NV PRIMARY PIGGYBACK SET

    MDR report key: 1133050 · Received August 22, 2008

    Report

    Report Number
    9613251-2008-00303
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 30, 2008
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    FPA
    PMA / PMN Number
    K971293
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AIR IN THE TUBING SET. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION VIA GRAVITY. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, AN UNSPECIFIED MEDICATION WAS DELIVERED IV PUSH THROUGH THE CLAVE Y-SITE. THE PATIENT NOTED THE AIR IN THE TUBING SET. THE AIR WAS REMOVED FROM THE TUBING SET AND THE THERAPY WAS RESUMED. THE CUSTOMER CONTACT REPORTED NO AIR WAS DELIVERED TO THE PATIENT. 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 LIFESHEILD NV PRIMARY PIGGYBACK SET 80-FPA FPA HOSPIRA, LTD. NA 551254W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK