BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2210713 · Received August 12, 2011

    Report

    Report Number
    6000001-2011-18716
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER RETURNED A COLLEAGUE INFUSION PUMP TO BAXTER WITH FAILURE CODE OF 16:310. DURING EVALUATION THE REPORTED PROBLEM WAS CONFIRMED, BUT NOT REPRODUCED. THE REPORTED MALFUNCTION WAS ATTRIBUTED TO A DEFECTIVE USER INTERFACE MODULE PRINTER CIRCUIT BOARD. THE USER INTERFACE MODULE PRINTER CIRCUIT BOARD WAS REPLACED TO FIX THE REPORTED PROBLEM. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.04.00 WHICH IS CATEGORIZED AS UNREMEDIATED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A DEVICE HISTORY REVIEW WAS PERFORMED FINDING THAT THE PUMP HAD A STUCK SLIDE CLAMP IN CHANNEL C DURING MANUFACTURING, HOWEVER, THE PUMP HEAD MODULE WAS REPLACED. THE DEVICE WAS RE-TESTED AND FOUND TO BE PERFORMING AS DESIGNED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 16:310. IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THIS EVENT MAY HAVE INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN.

    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