BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1183616 · Received October 4, 2008

    Report

    Report Number
    6000001-2007-00112
    Event Type
    Malfunction
    Date Received
    October 4, 2008
    Date of Event
    December 4, 2006
    Report Date
    December 4, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 JAN 03 2007. EVALUATION SUMMARY: THE CONDITION OF THE FAILED ACCURACY TEST WAS CONFIRMED DURING PRODUCT EVALUATION. INSPECTION OF THE DEVICE FOUND THAT THE FAILED ACCURACY TEST WAS CAUSED BY A FAULTY PUMP HEAD MECHANISM AND THEREFORE THE PUMP HEAD MECHANISM WAS REPLACED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION, THE PUMP FAILED AN ACCURACY TEST. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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