BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1200936 · Received October 20, 2008

    Report

    Report Number
    6000001-2007-01843
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    December 27, 2006
    Report Date
    December 27, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED 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 A PUMP WITH FAILURE CODE 814:01 ON POWER UP WAS CONFIRMED BY THE BAXTER REPAIR TECHNICIAN. INSPECTION OF THE DEVICE REVEALED DEPLETED MAIN BATTERIES, WHICH WERE REPLACED. THE DEVICE WAS TESTED BY THE REPAIR TECHNICIAN. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS BATTERY ISSUE IS CURRENTLY BEING INVESTIGATED, AND THE FAILURE CODE 814:01 ISSUE IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE TESTING, THE BAXTER TECHNICIAN REPORTED AN INFUSION PUMP WITH A FAILURE CODE 814:01 UPON POWER UP. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1