BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1183203 · Received October 3, 2008

    Report

    Report Number
    6000001-2007-00775
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    December 20, 2006
    Report Date
    December 20, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 08 2007. EVALUATION SUMMARY: THE PUMP IS IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS REPORT REPRESENTS ALL INFORMATION KNOWN BY THE REPORTER AT THIS TIME.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP STOPPED INFUSION ON ALL THREE CHANNELS, FAIL CODE 500. THIS EVENT OCCURRED DURING PATIENT USE. CHANNEL A WAS INFUSING LEVOPHED, CHANNEL B WAS INFUSIING NEOSYNEPHRINE AND CHANNEL C WAS INFUSING AMIDARONE. PATIENT WAS ADMITTED IN THE CARDIAC THORACIC UNIT (CTU). ACCORDING TO THE HOSPITAL REPRESENTATIVE 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 3 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1