BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1200503 · Received October 20, 2008

    Report

    Report Number
    6000001-2007-01725
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    January 8, 2007
    Report Date
    January 8, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED IN ACCORDANCE WITH INSTRUCTION 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 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 HEAD MODULE UNDERDELIVERY 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.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE TESTING, THE BAXTER TECHNICIAN REPORTED AN INFUSION PUMP WITH A CONDITION OF PUMP HEAD MODULE UNDERDELIVERY. 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 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1