BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1183647 · Received October 4, 2008

    Report

    Report Number
    6000001-2007-00776
    Event Type
    Malfunction
    Date Received
    October 4, 2008
    Date of Event
    December 14, 2006
    Report Date
    December 14, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 09 2007. EVALUATION SUMMARY: THE INFUSION PUMP WAS TESTED FOR FLOW ACCURACY AT 100 ML/HOUR, THE INFUSION PUMP FAILED THE ACCURACY TEST. THE SPECIFICATION OF THIS DEVICE IS +/-5%. THE REPORTED CONDITION OF PUMP FAILED ACCURACY TESTING WAS CONFIRMED BY THE BAXTER REPAIR TECHNICIAN. THE FAILURE WAS DETERMINED TO BE A FAULTY PUMP HEAD MODULE ASSEMBLY., WHICH WAS REPLACED. THE DEVICE WAS TESTED BY THE REPAIR TECHNICIAN AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE TESTING, THE BAXTER TECHNICIAN REPORTED AN INFUSION PUMP WITH CONDITION OF PUMP FAILED ACCURACY TESTING. PER THE SERVICE SHOP, THE HOSPITAL REPRESENTATIVE STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS KNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1