BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1024126 · Received April 5, 2008

    Report

    Report Number
    6000001-2007-04540
    Event Type
    Malfunction
    Date Received
    April 5, 2008
    Date of Event
    February 12, 2007
    Report Date
    February 12, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-12/13/05-019-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 FEB 21 2007. EVALUATION SUMMARY:DURING PRODUCT EVALUATION, A DEFECTIVE SHUTTLE MOTOR GEAR WAS OBSERVED ON THE PUMP HEAD MODULE ASSEMBLY. THE CUSTOMER REPORTED,THE FAILURE CODE 812:02 CONFIRMS THE DEFECTIVE MOTOR GEARS. THIS FAILURE CODE IS MANIFESTED AS A RESULT OF THE DEFECTIVE GEARS ON THE PUMP HEAD MODULE. THE PUMP HEAD MODULE WAS REPLACED AND THE DEVICE WAS TESTED. THE FACILITY REPORTED THE INFUSION PUMP WITH A FAILURE CODE 812:02 REPORTED TO HAVE OCCURRED DURING BIO-MED TESTING.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO BAXTER FOR SERVICE. DURING TESTING, THE BAXTER TECHNICIAN REPORTED AN INFUSION PUMP WITH A DEFECTIVE SHUTTLE MOTOR GEAR ON THE PUMP HEAD MODULE. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAS BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL INFORMATION IS KNOWN.

    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