BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1024054 · Received April 5, 2008

    Report

    Report Number
    6000001-2007-04686
    Event Type
    Malfunction
    Date Received
    April 5, 2008
    Date of Event
    February 14, 2007
    Report Date
    February 14, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION WAS COMPLETED. ERROR CODES 533:320 AND 403:317 WERE FOUND. THEY ARE ALL RELATED TO THE UIM BOARD WHICH WAS OUT OF SPECIFICATION AND WAS REPLACED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE THE DEVICE HAD DEFECTIVE UIM PCB WHICH WAS REPLACED AFTER PUMP HAD FAILURE CODES 403 AND 533. THERE WAS NO RECORD OF ANY PATIENT INJURY OR MEDICAL INTERVENTION.

    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