BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1150126 · Received August 19, 2008

    Report

    Report Number
    1150126
    Event Type
    Malfunction
    Date Received
    August 19, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 19, 2008
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    RN HUNG NEW IV LINE FOR PT AT 0330 PER PROTOCOL. WHEN THE INFUSION CHANNEL WAS RESTARTED, THE CHANNEL ALARMED "AIR IN LINE" FOR THE CYCLOSPORINE INFUSION. RN OPENED THE INFUSION CHANNEL TO CHECK THE ALARIS NITRO 2260 TUBING FOR AIR. RN SLIGHTLY STRETCHED AND FLICKED THE TUBING TO REMOVE AN AIR BUBBLE. THE TUBING POPPED NEAR THE TOP OF THE PORTION OF TUBING THAT SITS WITHIN THE ALARIS PUMP CHANNEL. THE RN IMMEDIATELY CLAMPED OFF BOTH ENDS OF THE RUPTURED TUBING, STOPPED THE INFUSION, AND ALERTED THE CHARGE NURSE, FOR ASSISTANCE. SPILL OF CHEMO WAS LIMITED TO A FEW DROPS TO THE RN'S HAND AND SCRUB PANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TUBING, IV FPA ALARIS MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR