BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1023906 · Received April 4, 2008

    Report

    Report Number
    6000001-2007-00693
    Event Type
    Malfunction
    Date Received
    April 4, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 11, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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 (UNDERINFUSING) WAS CONFIRMED DURING THE PRE-ACCURACY TEST. SERVICE REPLACED THE PUMP HEAD MODULE AND TESTED THE DEVICE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN UNDERINFUSING PUMP DURING BIO-MED TESTING. 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 CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1