BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1183598 · Received October 4, 2008

    Report

    Report Number
    6000001-2007-00308
    Event Type
    Malfunction
    Date Received
    October 4, 2008
    Date of Event
    December 11, 2006
    Report Date
    December 11, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 ON JAN 03, 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%. INSPECTION OF THE PUMP REVEALED DEFECTIVE PUMP HEAD MODULE CAUSED THE INACCURACY. THE PUMP HEAD MODULE WAS REPLACED. THE PUMP WAS TESTED FOR PROPER OPERATION AND PUMP FOUND TO FUNCTION PROPERLY.

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER, THE DEVICE FAILED ACCURACY TEST WITH UNDERDELIVERY. 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 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1