BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 CXE VOLUMETRIC INFUSION PUMP

    MDR report key: 1021540 · Received March 26, 2008

    Report

    Report Number
    6000001-2008-00192
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 27, 2008
    Report Date
    March 5, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: DURING PROD EVAL AT THE FACILITY, THE BIOMED ENGINEER CONCLUDED THAT THE COLLEAGUE PUMP WAS FUNCTIONING CORRECTLY, AND THE DEVICE WILL NOT BE RETURNED TO TECH SVC FOR EVAL.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE VOLUMETRIC PUMP WITH AN OVER-INFUSION. THE PROBLEM WAS IDENTIFIED DURING PT USE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADD'L INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1