BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 670160 · Received January 26, 2006

    Report

    Report Number
    6000001-2006-01354
    Event Type
    Malfunction
    Date Received
    January 26, 2006
    Date of Event
    December 1, 2005
    Report Date
    December 28, 2005
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN OBF WHICH FAILED THE FLOW TEST FOUND DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE 6201 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA