BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2213485 · Received August 16, 2011

    Report

    Report Number
    6000001-2011-19140
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    November 30, 2010
    Report Date
    May 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    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 CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:11 ON CHANNEL C WAS CONFIRMED IN THE PUMP'S EVENT HISTORY BY BAXTER CANADA PERSONNEL. THE ROOT CAUSE WAS NOT IDENTIFIED AS THIS CONDITION COULD NOT BE REPRODUCED. THE CHANNEL WAS CLEANED AND DRIED AS A PRECAUTIONARY MEASURE AND NO REPAIRS WERE REQUIRED FOR THE REPORTED PROBLEM AS THE DEVICE PASSED SUBSEQUENT TESTING. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING A REVIEW OF A COLLEAGUE INFUSION PUMP'S EVENT HISTORY BY BAXTER (B)(4) PERSONNEL, AN 810:11 FAILURE CODE ON CHANNEL C WAS FOUND. THIS EVENT INTERRUPTED DELIVERY. IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS A P1.5 COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.92.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PRE P1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1