BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2230490 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-21981
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 17, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED PROBLEM WAS NOT CONFIRMED OR REPRODUCED. THE ROOT CAUSE WAS NOT IDENTIFIED. NO FURTHER ACTION WAS TAKEN TO FIX THE REPORTED PROBLEM SINCE IT WAS NOT IDENTIFIED. ADDITIONAL INFORMATION: A DEVICE HISTORY REVIEW WAS PERFORMED FINDING ONE EXCEPTION DURING MANUFACTURING, HOWEVER, THE DEVICE WAS RE-TESTED AND FOUND TO BE PERFORMING AS DESIGNED. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. MANUAL TUBE RELEASE WAS ALSO REPLACED DURING PREVIOUS SERVICE. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WITH THE REPORTED CONDITION THAT THE "MANUAL TUBE RELEASE DEFECTIVE". THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THIS CONDITION WAS FOUND IN THE GENERAL NURSING DEPARTMENT. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION IS A REMEDIATED COLLEAGUE 2006(6.13.90).

    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