BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2223764 · Received August 25, 2011

    Report

    Report Number
    6000001-2011-20719
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A FLOGARD INFUSION PUMP WITH DAMAGED BATTERY WAS CONFIRMED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY A DEPLETED MAIN BATTERY DUE TO USE/USER ERROR. THE MAIN BATTERY WAS REPLACED TO CORRECT THE REPORTED CONDITION. THIS INVOLVED A REMEDIATED COLLEAGUE 2006 INFUSION PUMP WITH USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.90. 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 IN THE PROCESS OF BEING EVALUATED. 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 REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY; THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THIS CONDITION WAS FOUND IN THE CENTRAL SUPPLY DEPARTMENT. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. 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