BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1172954 · Received September 25, 2008

    Report

    Report Number
    6000001-2007-03974
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    January 12, 2007
    Report Date
    January 12, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 FEB 02 2007. EVALUATION SUMMARY:THE INFUSION PUMP WAS TESTED FOR ACCURACY AT 100ML/HOUR, THE INFUSION PUMP FAILED THE ACCURACY TEST. THE SPECIFICATION OF THIS DEVICE IS +/- 5%. INSPECTION OF THE DEVICE FOUND THAT THE ACCURACY FAILURE WAS CAUSED BY A FAULTY PUMP HEAD MECHANISM, AND THEREFORE THE PUMP HEAD MECHANISM WAS REPLACED.

    Description of Event or Problem · 1

    THE FACILITY RETURNED THE DEVICE FOR SERVICE. DURING SERVICE, THE PUMP HEAD MECHANISM FAILED THE ACCURACY TEST. 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