BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1183596 · Received October 4, 2008

    Report

    Report Number
    6000001-2007-01500
    Event Type
    Malfunction
    Date Received
    October 4, 2008
    Date of Event
    November 1, 2006
    Report Date
    November 21, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON JAN 16 2007. EVALUATION SUMMARY:FAILURE CODE 810:11 WAS CONFIRMED IN THE EVENT HISTORY. FAILURE CODE 810:11 IS AN AIR-IN-LINE SENSOR FAILURE. INSPECTION OF THE PUMP FOUND THAT THE AIR-IN-LINE SENSOR NEEDED CALIBRATION. THE AIR-IN-LINE SENSOR WAS RECALIBRATED. THE DEVICE WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH FAILURE CODE 810. THE EVENT WAS REPORTED TO HAVE OCCURRED PRIOR TO PATIENT USE. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1