BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1673860 · Received May 5, 2010

    Report

    Report Number
    6000001-2010-00510
    Event Type
    Malfunction
    Date Received
    May 5, 2010
    Date of Event
    April 27, 2010
    Report Date
    April 28, 2010
    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
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FACILITY'S BIOMEDICAL TECHNICIAN (BT) CALLED BAXTER TECHNICAL SUPPORT CONCERNING A COLLEAGUE INFUSION PUMP EXPERIENCING FAILURE CODE 810:11. WITH THE HELP OF BAXTER TECHNICAL SUPPORT, THE BT CHECKED AND CONFIRMED THE THE AIR IN LINE (AIL) PRINTED CIRCUIT BOARD (PCB) WAS OUT OF CALIBRATION. THE BT RE-CALIBRATED THE AIL PCB TO CORRECT THE REPORTED CONDITION. THE FACILITY WILL NOT BE SENDING THIS PUMP TO BAXTER FOR DEVICE EVALUATION OR REPAIR.HOWEVER, SHOULD THIS PUMP BE RECEIVED BY BAXTER FOR EVALUATION, OR IF ANY ADDITIONAL INFORMATION ABOUT THIS EVENT BECOMES AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE FOR THIS ISSUE IS CURRENTLY BEING INVESTIGATED THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:11, DUE TO THE PUMP'S AIR IN LINE PRINTED CIRCUIT BOARD BEING OUT OF CALIBRATION. THIS EVENT WAS REPORTED TO HAVE OCCURRED DURING SET PRIMING IN THE NEONATAL INTENSIVE CARE UNIT. THERE WAS NO REPORTED PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CXE VOLUMETRICINFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1