BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2231523 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22088
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF CHANNEL B FAILURE WAS CONFIRMED BY BAXTER PERSONNEL IN THE PUMP'S EVENT HISTORY. UPON FURTHER REVIEW OF THE EVENT HISTORY, QUALITY ENGINEERING FOUND THAT THE LAST FAILURE TO OCCUR ON CHANNEL B WAS FAILURE CODE OF 803:07. THE ROOT CAUSE WAS ASSIGNED TO THE BLUE SLIDE CLAMP THAT WAS LEFT IN THE CHANNEL B PUMP HEAD MODULE. THE BLUE SLIDE CLAMP WAS REMOVED FROM THE CHANNEL B PUMP HEAD MODULE TO CORRECT THIS CONDITION. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS 5.04.00 WHICH IS CATEGORIZED AS UNREMEDIATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH CHANNEL B FAILURE. IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THIS EVENT MAY HAVE INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN.

    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