BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSYRINGE INFUSION PUMP MODEL AS50

    MDR report key: 447452 · Received March 6, 2003

    Report

    Report Number
    6000001-2003-03282
    Event Type
    Malfunction
    Date Received
    March 6, 2003
    Date of Event
    February 1, 2003
    Report Date
    February 10, 2003
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY'S BIOMEDICAL TECH REPORTED AN INFUSION PUMP WITH FAILURE CODE M013050 FOUND DURING PT USE WITH NO PT INJURY OR MEDICAL INTERVENTION NEEDED. ALTHOUGH ATTEMPTS WERE MADE BY BAXTER TO OBTAIN ADD'L 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 LAST BAXTER SERVICE EVENT. NO ADD'L 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