BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2374364 · Received December 14, 2011

    Report

    Report Number
    6000001-2011-40836
    Event Type
    Malfunction
    Date Received
    December 14, 2011
    Date of Event
    November 21, 2011
    Report Date
    November 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF INOPERATIVE KEYPAD BUTTONS WAS NEITHER CONFIRMED NOR REPRODUCED DURING SERVICE EVALUATION BY BAXTER PERSONNEL. THE CAUSE WAS NOT IDENTIFIED, KEYPAD TESTS WERE PERFORMED AND THE DEVICE PASSED TEST. UPON REVIEW OF THE EVENT HISTORY LOG, THE QUALITY ENGINEER HAS IDENTIFIED FAILURE CODE 89:317:1029:00 AS THE REPORTED CONDITION. THE CAUSE OF THE FAILURE CODE WAS USE ERROR. NO REPAIRS WERE PERFORMED FOR THE REPORTED CONDITION. ADDITIONAL INFORMATION: A DEVICE HISTORY REVIEW WAS ALSO PERFORMED, FINDING THAT NO EXCEPTIONS WERE NOTED DURING THE MANUFACTURING OF THIS DEVICE. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS REPORTED PROBLEM WITH THIS PUMP. CORRECTED INFORMATION: THE USER INTERFACE MODULE SOFTWARE VERSION IS 5.07.00.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WHERE THE KEYPAD BUTTONS WERE INOPERATIVE. THE EVENT WAS REPORTED TO HAVE OCCURRED BEFORE USE. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION IS 5.04.00.

    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