BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2070080 · Received April 26, 2011

    Report

    Report Number
    6000001-2011-03205
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED ON-SITE AT THE CUSTOMER FACILITY. THE CONDITION OF FAILURE CODE 500:320:658:0000 WAS CONFIRMED THROUGH THE EVENT HISTORY. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED, THE USER INTERFACE MODULE KEYPAD WAS REPLACED AS A PRECAUTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    COLLEAGUE INFUSION PUMP WAS REPORTED ORIGINALLY FOR A FAILURE CODE 500:320:658:0000. IT IS UNKNOWN WHEN THE REPORTED CONDITION OCCURRED. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER (B)(4) PERSONNEL, THE DEVICE WAS FOUND TO HAVE EXPERIENCED A FAILURE CODE 500:320:658:0000, WHICH INTERRUPTED DELIVERY. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.92 CATEGORIZED AS REMEDIATED.

    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