BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1023876 · Received April 4, 2008

    Report

    Report Number
    6000001-2007-01136
    Event Type
    Malfunction
    Date Received
    April 4, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 11, 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
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF FAILURE CODE 810:04 WAS CONFIRMED IN THE PUMP'S EVENT HISTORY FILE DURING PRODUCT EVALUATION. INSPECTION OF THE DEVICE FOUND THAT THIS FAILURE CODE WAS CAUSED BY AN OUT OF CALIBRATION AIR IN LINE PRINTED CIRCUIT BOARD ON CHANNEL B. THE AIR IN LINE PRINTED CIRCUIT BOARD ON CHANNEL B WAS RECALIBRATED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP WITH FAILURE CODE 810:04. THIS PROBLEM WAS IDENTIFIED 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 3 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1