BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1193257 · Received October 14, 2008

    Report

    Report Number
    6000001-2007-04346
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 8, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE.LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA FEB 12, 2007. THE FACILITY REPORTED AN FAILURE CODE 810:11 PRIOR TO USE. EVALUATION SUMMARY: EVALUATION WAS PERFORMED AND THE CONDITION OF OUT OF CALIBRATION ON AIR IN LINE PRINTER CIRCUIT BOARD (AIL PCB) WAS CONFIRMED DUE TO FAILURE CODE 810:11. INSPECTION OF THE PUMP REVEALED OUT OF CALIBRATION ON AIR IN LINE PRINTER CIRCUIT BOARD (AIL PCB) CAUSED THE FAILURE CODE 810:11. RECALIBRATED THE AIR IN LINE PRINTER CIRCUIT BOARD (AIL PCB). THE PUMP WAS TESTED FOR PROPER OPERATION AND PUMP FOUND TO FUNCTION PROPERLY.

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER, AIR IN LINE PRINTER CIRCUIT BOARD (AIL PCB) WITH OUT OF CALIBRATION WAS FOUND. ACCORDING TO THE HOSPITAL REPRESENTATIVES THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION OR CONTACT WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1