BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2223649 · Received August 25, 2011

    Report

    Report Number
    6000001-2011-20689
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    October 21, 2010
    Report Date
    April 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER PERSONNEL, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4).EVALUATION SUMMARY:THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH AN 810:11 FAILURE CODE WAS CONFIRMED DURING PRODUCT EVALUATION. THE ROOT CAUSE WAS ASSIGNED TO THE AIR IN LINE PRINTED CIRCUIT BOARD BEING OUT OF CALIBRATION. THE AIR IN LINE PRINTED CIRCUIT BOARD WAS RECALIBRATED IN ORDER TO CORRECT THIS CONDITION. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    DURING REVIEW OF THE EVENT HISTORY BY A BAXTER SERVICE TECHNICIAN, IT WAS DETERMINED THAT FAILURE CODE 810:11 OCCURRED DURING DELIVERY ON (B)(6) 2010 CAUSING AN INTERRUPTION OF DELIVERY. THERE IS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.90 CATEGORIZED AS REMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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