BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1170885 · Received September 24, 2008

    Report

    Report Number
    6000001-2007-02706
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    January 3, 2007
    Report Date
    January 3, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 24 2007. EVALUATION SUMMARY:THE INFUSION PUMP WAS TESTED FOR FLOW ACCURACY AT 100 ML/HOUR, THE INFUSION PUMP FAILED THE ACCURACY TEST. THE SPECIFICATION OF THIS DEVICE IS +/-5%. THE REPORTED CONDITION WAS CONFIRMED DUE TO A DEFECTIVE PUMP HEAD MODULE (PHM). SERVICE REPLACED THE PHM AND TESTED THE DEVICE.

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED FOR SERVICE. DURING SERVICE TESTING. THE DEVICE FAILED THE ACCURACY TEST FOR INFUSION. ACCORDING TO THE FACILITY REPRESENTATIVE, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1