BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2213080 · Received August 16, 2011

    Report

    Report Number
    6000001-2011-19070
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 9, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WHICH "ALARMED" WAS CONFIRMED DURING PRODUCT EVALUATION. REVIEW OF THE EVENT HISTORY AND REPAIR-PRIMARY ACTIVITIES SHOW THAT FAILURE CODE 550:654 WAS THE LAST TO OCCUR BEFORE THE PUMP WAS SENT IN FOR SERVICE. THE ROOT CAUSE OF THIS CONDITION WAS ASSIGNED TO A FAULTY USER INTERFACE MODULE SPEAKER HARNESS. THE USER INTERFACE MODULE SPEAKER HARNESS WAS REPLACED TO CORRECT THIS CONDITION. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.09.90 WHICH IS CATEGORIZED AS A COLLEAGUE 2006.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE RECEIVED BY BAXTER 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 A COLLEAGUE INFUSION PUMP WHICH "ALARMED". IT IS UNKNOWN WHEN THIS EVENT OCCURRED; HOWEVER, IT OCCURRED DURING A ROUTINE CHECK BY PARAMEDICS BEFORE TAKING THE PUMP OUT ON THE TRUCK. THIS EVENT MAY HAVE INTERRUPTED DELIVERY. 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. 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 PRE P1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1