BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1832712 · Received September 13, 2010

    Report

    Report Number
    6000001-2007-01046
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    December 15, 2006
    Report Date
    December 15, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    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 (B)(4) 2007. EVALUATION SUMMARY: THE INFUSION PUMP WAS TESTED FOR FLOW ACCURACY AT 100ML/HR, THE PUMP FAILED THE ACCURACY TEST WITH A FLOW VALUE BELOW THE DESIRED AMOUNT. THE SPECIFICATION LIMIT FOR THIS PUMP IS +/-5%. THE PUMPHEAD WAS REPLACED AND THE DEVICE WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FROM CUSTOMER FOR SERVICE. DURING SERVICE BY BAXTER TECHNICIAN, THE DEVICE FAILED ACCURACY TEST. CUSTOMER REPORTED THERE WERE NO PATIENT INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

    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