BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2202971 · Received August 11, 2011

    Report

    Report Number
    6000001-2011-18410
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 PUMP WITH A FAILURE CODE 810:11 WAS CONFIRMED AND NOT REPRODUCED DURING PRODUCT EVALUATION. THE ROOT CAUSE OF THIS CONDITION WAS ASSIGNED TO THE AIR IN LINE BOARD BEING OUT OF CALIBRATION. THE AIR IN LINE PRINT CIRCUIT BOARD WAS RECALIBRATED TO CORRECT THIS CONDITION. FAILURE CODE 810:11 INDICATES AN AIR SENSOR ERROR (AIR SENSOR/CIRCUITS SATURATED). THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.09.90 WHICH IS CATEGORIZED AS A COLLEAGUE 2006.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE 810:11. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION NECESSARY. 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