BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 451499 · Received March 28, 2003

    Report

    Report Number
    6000001-2003-04435
    Event Type
    Malfunction
    Date Received
    March 28, 2003
    Date of Event
    March 1, 2003
    Report Date
    March 26, 2003
    Manufacturer
    BAXTER HEALTHCARE PLE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY'S TECHNICIAN REPORTED A FAIL CODE 512, WHICH OCCURRED DURING BIOMED TESTING. ADDITIONAL CONTACT INFORMATION WAS REQUESTED BUT NO ADDITIONAL CONTACT WAS INDENTIFIED. THE TECHNICIAN STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INCIDENT INVOLVING THIS PUMP SINCE THE LAST BAXTER SERVICE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA