BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 610199 · Received July 7, 2004

    Report

    Report Number
    6000001-2004-01086
    Event Type
    Malfunction
    Date Received
    July 7, 2004
    Date of Event
    May 1, 2004
    Report Date
    May 31, 2004
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTED AN INFUSION PUMP WITH A FAILURE CODE 800:320:831:0000. REVIEW OF THE EVENT HISTORY DETERMINED THAT FAILURE CODE 500:320:831:000 HAD ACTUALLY OCCURRED. INFO WAS NOT PROVIDED REGARDING WHETHER OR NOT THE FAILURE OCCURRED DURING AN INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. COLLEAGUE 3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN