BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1240118 · Received November 24, 2008

    Report

    Report Number
    6000001-2007-06007
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    April 16, 2007
    Report Date
    April 16, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 REPLACED. THE DEVICE WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION THE PUMP'S AIR-IN-LINE PRINTED CIRCUIT BOARD WAS FOUND TO BE OUT OF CALIBRATION. 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