BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2230881 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22014
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 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). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF THE DISPLAY HAS ROUND MARKS ON THE SCREEN WAS CONFIRMED AND REPRODUCED DURING PRODUCT EVALUATION. THE ROOT CAUSE WAS ASSIGNED TO A FAULTY MAIN DISPLAY THAT HAD SPOTS. THE MAIN DISPLAY WAS REPLACED IN ORDER TO CORRECT THIS CONDITION. ADDITIONAL INFORMATION: THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 6.13.90 WHICH IS CATEGORIZED AS A COLLEAGUE 2006. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. 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 COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF THE DISPLAY HAVING ROUND MARKS ON THE SCREEN. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING PROGRAMMING / SETUP IN THE STERILE PROCESSING DEPARTMENT. ACCORDING TO THE HOSPITAL REPRESENTATIVE, THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN. 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