BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1241546 · Received November 25, 2008

    Report

    Report Number
    6000001-2007-04316
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    February 1, 2007
    Report Date
    February 1, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-7/20/05-015-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEFECTIVE USER INTERFACE MODULE WAS CONFIRMED. FURTHER INSPECTION OF THE DEVICE CONFIRMED FAILURE CODE 804:22 IN THE EVENT HISTORY. THIS FAILURE CODE OCCURS AS A RESULT OF A DEFECTIVE USER INTERFACE MODULE. THE DEFECTIVE USER INTERFACE MODULE WAS REPLACED.

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER, THE INFUSION PUMP WAS FOUND TO CONTAIN A DEFECTIVE USER INTERFACE MODULE. 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 CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. N/A NA

    Patients

    Seq Age Sex Outcome Treatment
    1