BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1160281 · Received September 16, 2008

    Report

    Report Number
    6000001-2007-00703
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 12, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 JAN 08 2007. EVALUATION SUMMARY:EVALUATION WAS PERFORMED AND THE REPORTED CONDITION OF PUMP FAILURE CONFIRMED DUE TO FAILURE CODE 500:320:844:0000 MULTIPLE TIMES IN THE EVENT HISTORY. INSPECTION OF THE PUMP REVEALED DEFECTIVE FRONT BEZEL KEY PAD CAUSED FAILURE CODE 500:320:844:0000. REPLACED THE FRONT BEZEL. THE PUMP WAS TESTED FOR PROPER OPERATION AND PUMP FOUND TO FUNCTION PROPERLY. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH PUMP FAILURE. THIS EVENT OCCURRED DURING PATINET USE 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