BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER HEALTHCARE CORP. AP II

    MDR report key: 266258 · Received February 28, 2000

    Report

    Report Number
    MW1018262
    Event Type
    Malfunction
    Date Received
    February 28, 2000
    Date of Event
    December 2, 1999
    Report Date
    February 1, 2000
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MORPHINE DRIP ADMINISTERED THROUGH PCA (PT CONTROLLED ANALGESIA) PUMP. NO ANALGESIA ADMINISTERED ALTHOUGH DEVICE PRINTOUT INDICATED FULL DISCHARGE. PRINTOUT INDICATED 8 ML LEFT IN BAG, WHEN IN FACT 105 ML WERE LEFT IN BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER HEALTHCARE CORP. AP II MINI-INFUSION PUMP MEA BAXTER HEALTHCARE CORP. AP II *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR