BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2152093 · Received July 7, 2011

    Report

    Report Number
    6000001-2011-10631
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 29, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF DUPLICATED MESSAGES AT THE BOTTOM OF THE DISPLAY WAS CONFIRMED DURING PRODUCT EVALUATION. THE ASSIGNABLE CAUSE WAS A FAULTY MAIN DISPLAY. THE MAIN DISPLAY WAS REPLACED TO CORRECT THE REPORTED CONDITION. THE USER INTERFACE MODULE SOFTWARE VERSION IS 6.13.90.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER 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 CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WITH A DUPLICATE MESSAGE AT THE BOTTOM OF THE MAIN DISPLAY; THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO PATIENT INVOLVED; THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SOFTWARE VERSION IS CURRENTLY UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PRE P1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1