BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1160937 · Received September 17, 2008

    Report

    Report Number
    6000001-2007-04601
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    February 1, 2007
    Report Date
    February 5, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 ON FEB 23 2007. EVALUATION SUMMARY:DURING ON-SITE DEVICE EVALUATION, THE TECHNICIAN OBSERVED MULTIPLE AIR DETECTED SETS IN THE EVENT HISTORY AFTER ADVANCE AIR CLEARED WAS PERFORMED, HOWEVER THE CONDTION WAS NOT DUPLICATED. THIS AIL SENSOR READINGS VARIABLE WHEN PRIME TUBING WAS LOADED WAS FOUND TO BE OUT OF SPECIFICATIONS. THE PUMP HEAD MODULE WAS REPLACE AND THE DEVICE WAS TESTED FOUND TO BE FUNCTIONAL PER SPECIFICATIONS.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH AIR IN LINE ALARM FAILURE. THE FAILURE WAS REPORTED TO HAVE OCCURRED DURING BIOMED TESTING. THE HOSPITAL REPRESENTATIVE STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1