BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD VENTED SECONDARY W/BLUNT CANNULA

    MDR report key: 1061813 · Received June 13, 2008

    Report

    Report Number
    9613251-2008-00175
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 19, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K912103
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WERE DISCARDED.

    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 THE PROXIMAL PORTS OF UNSPECIFIED PRIMARY TUBING SETS AND WERE BEING USED FOR PIGGYBACK DELIVERIES OF UNSPECIFIED ANTIBIOTICS VIA UNSPECIFIED PUMPS. THE PRIMARY SOLUTION CONTAINERS WERE LOWERED BELOW THE SECONDARY SOLUTION CONTAINERS AND THE DELIVERIES WERE STARTED. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE NURSES NOTED THAT THE ANTIBIOTICS HAD NOT DELIVERED. THE TUBING SETS WERE REPLACED AND 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 VENTED SECONDARY W/BLUNT CANNULA 80-FPA FPA HOSPIRA LTD. NA UNK

    Patients

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