BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1190003 · Received October 8, 2008

    Report

    Report Number
    6000001-2007-02954
    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: THE CONDITION OF FAIL CODE 814:04 WAS CONFIRMED. FAIL CODE 814:04 WAS DUE TO CONTAMINATION ON THE PUMP HEAD MODULE. THE PUMP HEAD MODULE WAS REPLACED. THIS ISSUE IS CURRENTLY BEING INVESTIGATED UNDER CAPA. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FRO THIS PRODUCT FOR THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE BAXTER FIELD SERVICE ENGINEER NOTED AN INFUSION PUMP WITH FAILURE CODE 814:04 DURING BIOMED TESTING. THE HOSPITAL REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS 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