BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1024023 · Received April 5, 2008

    Report

    Report Number
    6000001-2007-01919
    Event Type
    Malfunction
    Date Received
    April 5, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 27, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED FAILURE CODE 810:11 WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THE CAUSE OF THE FAILURE CODE WAS DUE TO THE AIR IN LINE PRINTED CIRCUIT BOARD BEING OUT OF CALIBRATION. THE AIR IN LINE PRINTED CIRCUIT BOARD WAS RECALIBRATED. THE DEVICE WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL.

    Description of Event or Problem · 1

    A BAXTER REPRESENTATIVE REPORTED TO CUSTOMER SERVICE A PUMP WITH FAILURE CODE 810:11. THIS FAILURE CODE OCCURRED DURING BIO-MED TESTING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1