BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSYRINGE INFUSION PUMP MODEL AS50

    MDR report key: 466096 · Received May 16, 2003

    Report

    Report Number
    6000001-2003-06615
    Event Type
    Malfunction
    Date Received
    May 16, 2003
    Date of Event
    April 1, 2003
    Report Date
    April 25, 2003
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY'S BIOMEDICAL TECHNICIAN REPORTED AN INFUSION PUMP WITH FAILURE CODE L000025. ALTHOUGH ATTEMPTS WERE MADE BY BAXTER TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTING FACILITY, DETAILS WERE NOT AVAILABLE REGARDING PATIENT STATUS, MEDICAL INTERVENTION, PATIENT INJURY, AGE OF PATIENT, MEDICATION INVOLVED OR THE SET UP OF THE INFUSION DEVICE. THE HOSPITAL REPRESENTATIVE STATED THEY HAVE NO RECORD OF ANY PATIENT INCIDENT INVOLVING THE PUMP SINCE THE LAST BAXTER SERVICE EVENT. NO ADDITIONAL CONTACT INFORMAITON 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 UNKNOWN