BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 701707 · Received February 9, 2006

    Report

    Report Number
    6000001-2006-02107
    Event Type
    Malfunction
    Date Received
    February 9, 2006
    Date of Event
    January 1, 2006
    Report Date
    January 16, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-7/20/05-015-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AN INFUSION PUMP WITH FAILURE CODE 12:303:0002. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE DEVICE WAS IN PATIENT USE WHEN THE EVENT OCCURRED. NO RECORD OF ANY PATIENT INCIDENT INVOLVING THE PUMP NO PATIENT INJURY HAD BEEN REPORTED.

    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