BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2231455 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22070
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH AN AIR DETECTED ALARM FOUND IN THE PUMP'S EVENT HISTORY WAS CONFIRMED BUT NOT DUPLICATED DURING PRODUCT EVALUATION. ALTHOUGH THE AIR IN LINE PRINTED CIRCUIT BOARD WAS FOUND TO BE DEFECTIVE, THE ROOT CAUSE OF THE CONDITION COULD NOT BE DETERMINED. THE AIR IN LINE PRINTED CIRCUIT BOARD WAS REPLACED FOR THIS CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    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. 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.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER CANADA PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED AN AIR DETECTED ALARM, WHICH INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION 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 5.08.92.

    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