BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1233025 · Received November 18, 2008

    Report

    Report Number
    6000001-2007-05556
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    March 11, 2007
    Report Date
    March 29, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS EVALUATED ON 04/05/07, AND THE REPORTED FAILURE CODE (810:04 - AIR SENSOR FAILURE) THAT WAS REPORTED TO HAVE CAUSED THE PUMP TO SHUTDOWN DURING PATIENT INFUSION WAS NOT CONFIRMED IN THE EVENT HISTORY OR DURING TESTING. DURING EVALUATION, DEPLETED MAIN BATTERIES WERE FOUND WHICH COULD HAVE CAUSED AN UNEXPECTED SHUTDOWN OF THE PUMP. THE BATTERIES WERE REPLACED. THE PUMP WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL.

    Description of Event or Problem · 1

    THE FACILITY INITIALLY REPORTED TO BAXTER IN 2007, AN INFUSION PUMP WITH FAILURE CODE 810:04. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING PATIENT USE. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION WAS SUPPLIED. BAXTER OBTAINED ADDITIONAL INFORMATION THROUGH A FOLLOW-UP PHONE CONVERSATION WITH THE FACILITY¿S INITIAL REPORTER, ON THE FOLLOWING MONTH. THE INITIAL REPORTER STATED THAT THE EVENT OCCURRED DURING PATIENT INFUSION AND THAT THE PUMP STOPPED INFUSING DUE TO THE INITIALLY REPORTED FAILURE CODE 810:04. THE FACILITY REPRESENTATIVE STATED THAT NO FURTHER INFORMATION WAS AVAILABLE FROM THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. N/A NA

    Patients

    Seq Age Sex Outcome Treatment
    1