BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1023213 · Received April 4, 2008

    Report

    Report Number
    6000001-2007-01668
    Event Type
    Malfunction
    Date Received
    April 4, 2008
    Date of Event
    December 22, 2006
    Report Date
    December 22, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-7/20/05-015-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 16 2007. EVALUATION SUMMARY:THE REPORTED CONDITION OF FAILURE CODE 703 ON CHANNELS B AND C WAS CONFIRMED IN THE EVENT HISTORY BY THE BAXTER REPAIR TECHNICIAN. INSPECTION OF THE DEVICE REVEALED THE FAILURE WAS CAUSED BY A DEFECTIVE UIM PCB (USER INTERFACE MECHANISM PRINTED CIRCUIT BOARD), WHICH WAS REPLACED. THE DEVICE WAS TESTED BY THE REPAIR TECHNICIAN AND RETURNED TO SERVICE. 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.

    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 703 ON CHANNELS B AND C. PER THE SERVICE SHOP, THE HOSPITAL REPRESENTATIVE STATED THAT THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS KNOWN.

    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