BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2222304 · Received August 24, 2011

    Report

    Report Number
    6000001-2011-20599
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 11, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).EVALUATION SUMMARY:THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A PUMP HEAD FAILURE WAS CONFIRMED DURING PRODUCT EVALUATION. THE ROOT CAUSE OF THIS CONDITION WAS ASSIGNED TO CORROSION. THE PUMP HEAD MODULE WAS REPLACED TO CORRECT THIS CONDITION.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). 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 PUMP HEAD FAILURE; THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THIS CONDITION WAS FOUND UPON POWER UP. 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