BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1190022 · Received October 8, 2008

    Report

    Report Number
    6000001-2007-02878
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 4, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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 JAN 25, 2007. EVALUATION SUMMARY: FAILURE CODE 814:04 WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT CAUSE OF THE REPORTED FAILURE CODE WAS DUE TO A DEFECTIVE AIR-IN-LINE PRINTED CIRCUIT BOARD. THE AIR-IN-LINE PRINTED CIRCUIT BOARD WAS REPLACED. THE PUMP WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS CURRENTLY BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    A BAXTER REPRESENTATIVE REPORTED TO CUSTOMER SERVICE A PUMP WITH FAILURE CODE 814:04. THIS FAILURE CODE OCCURRED DURING BIO-MED TESTING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1