BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1122190 · Received August 15, 2008

    Report

    Report Number
    6000001-2008-00465
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 28, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PUMP IS IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION, OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP WITH FAILURE CODE 715:00 ON CHANNEL C DURING AN INFUSION. THE FAILURE OCCURRED DURING PATIENT USE WHILE THE INFUSION WAS RUNNING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1