BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER

    MDR report key: 542401 · Received July 30, 2004

    Report

    Report Number
    542401
    Event Type
    Malfunction
    Date Received
    July 30, 2004
    Date of Event
    June 7, 2004
    Report Date
    July 30, 2004
    Manufacturer
    BAXTER HEALTHCARE INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EPIDURAL PUMP ALARMED AIR IN LINE. SMALL AIR BUBBLE SEEN. NURSE LEFT ROOM, CALLED ANESTHESIA TO CHANGE TUBING. WHEN NURSE REENTERED THE ROOM THE TUBING WAS SEVERED AT THE POINT WHERE THE TUBING COMES OUT OF THE PUMP. TUBING WAS CLAMPED AT THE TIME AND THERE WAS NO HARM TO THE PATIENT. BAXTER AIR ELIMINATING SPIKE PUMP SET FOR 500ML BAG COVER 2.8ML, 3.1M (123")

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER AIR ELIMINATING SPIKE PUMP SET FOR 500ML BAG COVER(2L3221) FPA BAXTER HEALTHCARE INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *