BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2073209 · Received April 29, 2011

    Report

    Report Number
    6000001-2011-03305
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 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

    (B)(4). THE REPORTED CONDITION OF 810:04 WAS CONFIRMED DURING REVIEW OF THE EVENT HISTORY LOG. THE ASSIGNABLE CAUSE WAS AN OUT OF CALIBRATION AIR IN LINE (AIL) PRINTED CIRCUIT BOARD (PCB). THE AIL PCB WAS RECALIBRATED TO CORRECT THE REPORTED CONDITION. ADDITIONAL INFORMATION: THE USER INTERFACE MODULE SOFTWARE VERSION IS 5.09.90. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER, THE COLLEAGUE INFUSION PUMP WAS FOUND TO CONTAIN A MALFUNCTION OF FAILURE 810:04. THIS EVENT OCCURRED DURING INFUSION WHICH CAUSED AN INTERRUPTION DURING DELIVERY AND WAS FOUND DURING PRODUCT EVALUATION. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION IS CURRENTLY UNKNOWN.

    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