BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1240227 · Received November 24, 2008

    Report

    Report Number
    6000001-2007-06148
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    April 1, 2007
    Report Date
    April 12, 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

    FAILURE CODE 810:04 WAS INITIALLY REPORTED BY THE FACILITY. THIS FAILURE CODE OCCURRED BEFORE USE. EVALUATION SUMMARY: DURING PRODUCT EVALUATION THE AIR-IN-LINE PRINTED CIRCUIT BOARD WAS CONFIRMED TO BE OUT OF SPECIFICATION. INSPECTION OF THE DEVICE FOUND THAT FAILURE CODE 810:04 WAS CAUSED BY THE AIR-IN-LINE PRINTED CIRCUIT BOARD BEING OUT OF SPECIFICATION. THE AIR-IN-LINE PRINTED CIRCUIT BOARD WAS RECALIBRATED. THE PUMP WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL.

    Description of Event or Problem · 1

    DURING SERVICE, THE TECHNICIAN FOUND AN OUT OF CALIBRATION AIR-IN-LINE PRINTED CIRCUIT BOARD. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE.

    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