BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2240021 · Received September 8, 2011

    Report

    Report Number
    6000001-2011-23402
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF "UPON POWER UP IT DISPLAYS A C FAILURE, SCREEN WENT DARKER AND COULD NO READ IT " WAS CONFIRMED BY BAXTER PERSONNEL DURING PRODUCT EVALUATION. THE QUALITY ENGINEER HAS DETERMINED THAT THIS CONDITION WAS A RESULT OF A 701:XX FAILURE CODE AND DETERMINED THE CAUSE TO BE A RESULT OF CORROSION ON THE PUMP HEAD MODULE (PHM). THE PHM ASSEMBLY WAS REPLACED TO CORRECT THIS CONDITION. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.04.00 WHICH IS CATEGORIZED AS UNREMEDIATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. 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 REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WITH A CHANNEL C FAILURE IN WHICH THE SCREEN WENT "DARKER AND COULD NOT READ IT." THIS CONDITION WAS FOUND IN THE CENTRAL STERILE DEPARTMENT UPON POWER UP. THERE WAS NO PATIENT INVOLVED AND NO REPORTED PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. THE SOFTWARE VERSION IS CURRENTLY UNKNOWN AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1