BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSYRINGE INFUSION PUMP MODEL AS50

    MDR report key: 453657 · Received April 7, 2003

    Report

    Report Number
    6000001-2003-04813
    Event Type
    Malfunction
    Date Received
    April 7, 2003
    Date of Event
    March 1, 2003
    Report Date
    March 11, 2003
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY'S BIOMEDICAL TECH REPORTED AN INFUSION PUMP WITH FAILURE CODE L000025. ALTHOUGH ATTEMPTS WERE MADE BY BAXTER TO OBTAIN ADDITIONAL INFO FROM THE REPORTING FACILITY, DETAILS WERE NOT AVAILABLE REGARDING PT STATUS, MEDICAL INTERVENTION, PT INJURY, AGE OF PT, MEDICATION INVOLVED OR THE SET UP OF THE INFUSION DEVICE. THE HOSP REP STATED THEY HAVE NO RECORD OF ANY PT INCIDENT INVOLVING THE PUMP SINCE THE BAXTER SERVICE 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 UNKNOWN