BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE P1.7

    MDR report key: 2113549 · Received June 3, 2011

    Report

    Report Number
    6000001-2011-07075
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    March 18, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED ON-SITE AT THE CUSTOMER FACILITY. THE CONDITION WAS CONFIRMED THROUGH REVIEW OF THE EVENT HISTORY AND WAS FOUND TO BE DUE TO A LOOSE MAIN SPEAKER HARNESS. THE HARNESS WAS REPLACED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER PERSONNEL, IT WAS FOUND IN THE EVENT HISTORY THAT A COLLEAGUE INFUSION PUMP EXPERIENCED FAILURE CODE 550 CAUSED BY A LOOSE SPEAKER HARNESS, WHICH MAY HAVE FAILED TO AUDIBLY ALARM. THERE WAS NO PATIENT INVOLVED; THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.90 CATEGORIZED AS REMEDIATED.

    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