BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1231523 · Received November 18, 2008

    Report

    Report Number
    6000001-2007-05532
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    March 1, 2007
    Report Date
    March 14, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    2005-019-MD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: FAILURE CODE 810:11, AN AIR SENSOR ERROR, WAS INITIALLY REPORTED BY THE FACILITY AND OCCURRED DURING BIOMED TESTING. EVALUATION SUMMARY: DURING PRODUCT EVALUATION, THE AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB) VALUES WERE FOUND TO BE OUT OF SPECIFICATION. THE AIL PCB WAS RECALIBRATED.

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER, THE INFUSION PUMP WAS FOUND TO CONTAIN AN AIR-IN-LINE PRINTED CIRCUIT BOARD THAT WAS OUT-OF-CALIBRATION. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. N/A NA

    Patients

    Seq Age Sex Outcome Treatment
    1