BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS50 INFUSION PUMP

    MDR report key: 1040728 · Received December 13, 2007

    Report

    Report Number
    6000001-2007-11166
    Event Type
    Injury
    Date Received
    December 13, 2007
    Date of Event
    October 8, 2007
    Report Date
    November 15, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K961225
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AS50 INFUSION PUMP 80FPA FRN BAXTER HEALTHCARE PTE. LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening