BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1023034 · Received April 3, 2008

    Report

    Report Number
    6000001-2007-02513
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    September 6, 2006
    Report Date
    September 6, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE INFUSION PUMP WAS TESTED FOR FLOW ACCURACY AT 100ML/HR, THE PUMP FAILED THE ACCURACY TEST WITH A FLOW VALUE BELOW THE DESIRED AMOUNT. THE SPECIFICATION LIMIT FOR THIS PUMP IS +/-5%. THE PUMPHEAD WAS REPLACED AND THE DEVICE WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FROM CUSTOMER FOR SERVICE. DURING SERVICE BY BAXTER TECHNICIAN, THE DEVICE FAILED ACCURACY TEST WITH UNDERDELIVERY. CUSTOMER REPORTED THERE WERE NO PATIENT INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

    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