BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSO.R. PUMP

    MDR report key: 459000 · Received May 5, 2003

    Report

    Report Number
    6000001-2003-05975
    Event Type
    Malfunction
    Date Received
    May 5, 2003
    Date of Event
    July 15, 2002
    Report Date
    July 15, 2002
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BIOMEDICAL TECHNICIAN FOR THE FACILITY REPROTED THE UNIT FAILED ACCURACY TESTING AS AN OBF. THE AMOUNT OF INACCURACY AND METHOD OF TESTING WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSO.R. PUMP SYRINGE PUMP FRN BAXTER HEALTHCARE (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN