BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 518229 · Received January 27, 2004

    Report

    Report Number
    6000001-2004-00114
    Event Type
    Malfunction
    Date Received
    January 27, 2004
    Date of Event
    January 1, 2004
    Report Date
    January 13, 2004
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH FAILURE CODE 12:303:984:0002. INFO REGARDING WHETHER OR NOT THE DEVICE WAS IN USE ON A PT WHEN THIS FAILURE OCCURRED WAS NOT AVAILABLE, NO ADDITIONAL CONTACT INFO WAS PROVIDED. THE HOSP REP STATED THERE HAVE BEEN NO REPORTS OF ANY PT INCIDENT INOLVING THIS PUMP SINCE THE LAST BAXTER SERVICE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN