BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 529222 · Received February 26, 2004

    Report

    Report Number
    6000001-2004-00298
    Event Type
    Malfunction
    Date Received
    February 26, 2004
    Date of Event
    February 1, 2004
    Report Date
    February 11, 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

    FAILURE CODE 12:303:984:0002. INFO WAS NOT PROVIDED REGARDING WHETHER OR NOT THE FAILURE OCCURRED DURING AN INFUSION. THE HOSP REP STATED THAT THEY HAVE NO RECORD OF ANY PT INCIDENT INVOLVING THE PUMP SINCE THE LAST BAXTER SVC EVENT. ALTHOUGH ATTEMPTS WERE MADE BY BAXTER, DETAILS WERE NOT AVAILABLE REGARDING ADD'L CONTACT INFO, PT DEMOGRAPHICS, MEDICATION INVOLVED, OR PUMP PROGRAMMING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN