BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2222303 · Received August 24, 2011

    Report

    Report Number
    6000001-2011-20600
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A DUPLICATE SCREEN WAS NOT CONFIRMED OR REPRODUCED DURING PRODUCT EVALUATION. BAXTER QUALITY ENGINEERS WERE UNABLE TO CONFIRM THE CUSTOMER REPORTED PROBLEM AND NO OTHER ANCILLARY ISSUES COULD BE POTENTIALLY IDENTIFIED AS THE REPORTED COMPLAINT. NO REPAIRS WERE NECESSARY. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 6.13.90 WHICH IS CATEGORIZED AS A COLLEAGUE 2006. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO ABNORMALITY WAS OBSERVED IN THE MANUFACTURING OF THIS DEVICE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WITH A DUPLICATE SCREEN; THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THIS EVENT OCCURRED IN THE BIOMEDICAL SERVICE DEPARTMENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT, 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