BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSYRINGE INFUSION PUMP MODEL AS50

    MDR report key: 453674 · Received April 7, 2003

    Report

    Report Number
    6000001-2003-04831
    Event Type
    Malfunction
    Date Received
    April 7, 2003
    Date of Event
    March 1, 2003
    Report Date
    March 12, 2003
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY'S BIOMEDICAL TECH REPORTED AN INFUSION PUMP WITH FAILURE CODE L000025 FOUND DURING BIOMEDICAL TESTING. THE HOSP REP STATED THEY HAVE NO RECORD OF ANY PT INCIDENT INVOLVING THE PUMP SINCE THE LAST BAXTER EVENT. NO ADDITIONAL CONTACT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSYRINGE INFUSION PUMP MODEL AS50 INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. AS50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA