BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1832734 · Received September 13, 2010

    Report

    Report Number
    6000001-2007-02049
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    December 6, 2006
    Report Date
    December 6, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 (B)(4) 2007. EVALUATION SUMMARY: THE REPORTED CONDITION OF FAILED ACCURACY WAS CONFIRMED. THE PUMP HEAD MODULE WAS REPLACED. 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%.

    Description of Event or Problem · 1

    THE FACILITY RETURNED THE DEVICE FOR SERVICE. DURING SERVICE THE BAXTER REPAIR TECHNICIAN REPORTED FAILED ACCURACY TEST. THE HOSPITAL REPRESENTATIVE STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INCIDENT INVOLVING THIS PUMP. NO ADDITIONAL INFORMATION IS 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