BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP.

    MDR report key: 1024017 · Received April 5, 2008

    Report

    Report Number
    6000001-2007-01917
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 ON JAN 17 2007. EVALUATION SUMMARY:THE REPORTED CONDITION OF AIR IN LINE ERRORS WAS CONFIRMED AS FALSE AIR IN LINE ALARMS. INSPECTION OF THE DEVICE FOUND THAT CAUSE OF THE REPORTED FAILURE WAS DUE TO THE AIR IN LINE SENSOR BEING OUT OF CALIBRATION AS A RESULT OF A DAMAGED AIR IN LINE PRINTED CIRCUIT BOARD. THE AIR IN LINE PRINTED CIRCUIT BOARD WAS REPLACED AND CALIBRATED. THE PUMP WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS CURRENTLY BEING INVESTIGATED UNDER CAPA, WHICH WAS OPENED IN 2005.

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO CUSTOMER SERVICE A PUMP WITH AIR IN LINE ERRORS. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. 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 CX VOLUMETRIC INFUSION PUMP. INFUSION PUMP. FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1