BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE P1.7

    MDR report key: 2180595 · Received July 27, 2011

    Report

    Report Number
    6000001-2011-15071
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED MALFUNCTION OF "THE PUMP WAS RUNNING ON A PATIENT. ALL 3 CHANNELS FLASHED UP AND THE PUMP STOPPED WORKING COMPLETELY" WAS CONFIRMED AS FAILURE CODE 522:320:666:0000. THE ROOT CAUSE WAS ATTRIBUTED TO A CUT/DAMAGED SPEAKER HARNESS. NO REPAIRS WERE MADE AT THIS TIME. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. A DEVICE HISTORY REVIEW WAS PERFORMED FINDING NO EXCEPTION, NONCONFORMANCE, OR REWORK THAT OCCURRED DURING THE MANUFACTURING OF THE COMPLAINT LOT OR SERIAL NUMBER. THIS INVOLVED A COLLEAGUE VERSION 1.7 INFUSION PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 8.11.00. THIS ISSUE HAS BEEN ESCALATED TO CAPA. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    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. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE RECEIVED BY BAXTER (B)(4) FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO BAXTER (B)(4) A COLLEAGUE INFUSION PUMP WHERE "THE PUMP WAS RUNNING ON A PATIENT. ALL 3 CHANNELS FLASHED UP AND THE PUMP STOPPED WORKING COMPLETELY". THIS EVENT OCCURRED DURING AN INFUSION AND INTERRUPTED DELIVERY. THE PATIENT DID NOT RECEIVE THE UNCONFIRMED DRUGS AS REQUIRED. IT IS UNKNOWN IN WHICH CARE AREA THIS EVENT OCCURRED. THERE WAS NO REPORT OF PATIENT 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 P1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1