BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 523497 · Received February 13, 2004

    Report

    Report Number
    6000001-2004-00218
    Event Type
    Malfunction
    Date Received
    February 13, 2004
    Date of Event
    January 26, 2004
    Report Date
    January 26, 2004
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH FAILURE CODE 12:303:984:0002 DURING BIO MED TESTING. NO ADDITIONAL CONTACT INFO WAS PROVIDED. THE HOSP REP STATED THERE HAVE BEEN NO REPORTS OF ANY PT INCIDENT INVOLVING THIS PUMP SINCE THE LAST BAXTER SERVICE EVENT.

    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 NA