BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP

    MDR report key: 2010712 · Received March 8, 2011

    Report

    Report Number
    6000001-2011-01679
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    December 8, 2010
    Report Date
    February 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED BUT NOT DUPLICATED. THE ASSIGNABLE CAUSE WAS A FAULTY CHANNEL B PUMPHEAD MODULE. THE CHANNEL B PUMPHEAD MODULE HAS BEEN REPLACED. ADDITIONAL: THE ROOT CAUSE FOR THIS ISSUE IS CURRENTLY BEING INVESTIGATED THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION MDQ-CAPA (B)(4).

    Description of Event or Problem · 1

    DURING BAXTER'S REVIEW OF THE EVENT HISTORY FOR ANOTHER REPORT, IT WAS DISCOVERED THAT FAILURE CODE 808:02 OCCURRED DURING INFUSION, WHICH CAUSED AN INTERRUPTION DURING DELIVERY. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.92, CATEGORIZED AS REMEDIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1