BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3VOLUMETRIC INFUSION PUMP

    MDR report key: 1345744 · Received March 9, 2009

    Report

    Report Number
    6000001-2009-00192
    Event Type
    Malfunction
    Date Received
    March 9, 2009
    Date of Event
    February 17, 2009
    Report Date
    February 17, 2009
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION, OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE PUMP WITH A FAILURE CODE 4:311:1985:0050. THE FAILURE CODE OCCURRED DURING PATIENT INFUSION WHILE IN PIGGY BACK MODE. 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 3VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1