BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2230251 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-21956
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF "UNKNOWN FAILURE" WAS CONFIRMED BY BAXTER QUALITY ENGINEERING AS FAILURE CODE 804:26. THIS CONDITION WAS A SOFTWARE FAILURE THAT COULD NOT BE DUPLICATED DURING PRODUCT EVALUATION. NO REPAIR WAS NECESSARY FOR THE REPORTED CONDITION. ADDITIONAL INFORMATION: THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.09.90 WHICH IS CATEGORIZED AS A COLLEAGUE 2006. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE HAS NOT BEEN SERVICED FOR THE REPORTED CONDITION PRIOR TO THIS EVENT. A DEVICE HISTORY REVIEW WAS PERFORMED FINDING NO EXCEPTION, NONCONFORMANCE, OR REWORK THAT OCCURRED DURING THE MANUFACTURING OF THE COMPLAINT LOT OR SERIAL NUMBER. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF AN UNKNOWN "FAILURE". THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO REPORT OF PATIENT/USER INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP 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