BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER AP-II

    MDR report key: 249004 · Received November 5, 1999

    Report

    Report Number
    249004
    Event Type
    Malfunction
    Date Received
    November 5, 1999
    Date of Event
    September 14, 1999
    Report Date
    November 5, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP IV SYSTEMS DIV/ELECTRONIC INF. SYS.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS BAXTER PCA ANALGSIA PUMP DOES NOT ALARM WHEN THE TUBING IS KINKED OR OCCLUDED BETWEEN THE MEDICATION BAG AND THE PUMP. THEREFORE, NO ALARM SOUNDS FOR THIS UPSTREAM OCCLUSION ALTHOUGH THE PUMP RECORDED THAT THE PT RECEIVED ALL THE PAIN MEDICINE, THE BAG WAS COMPLETELY FULL WHEN THE PUMP ALARMED TO CHANGE THE "EMPTY" BAG OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER AP-II PCA PUMP MEA BAXTER HEALTHCARE CORP IV SYSTEMS DIV/ELECTRONIC INF. SYS. AP II *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other