BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2220369 · Received August 23, 2011

    Report

    Report Number
    6000001-2011-20343
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    January 12, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE UNIT WAS RECEIVED FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT NO SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:11 WAS CONFIRMED DURING PRODUCT EVALUATION. THE DEVICE PASSED ALL TESTS PER PROCEDURE. THEREFORE, NO ASSIGNABLE CAUSE COULD BE PROVIDED AND NO REPAIR WAS NECESSARY FOR THE REPORTED CONDITION.

    Description of Event or Problem · 1

    BAXTER CANADIAN TECHNICAL SERVICES FOUND A COLLEAGUE INFUSION PUMP WITH THE FAILURE CODE 810:11, WHICH OCCURRED DURING THERAPY CAUSING AN INTERRUPTED DELIVERY. THIS CONDITION WAS FOUND DURING SERVICE. THERE WAS NO REPORTED PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 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