BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1161250 · Received September 17, 2008

    Report

    Report Number
    6000001-2007-04824
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    February 1, 2007
    Report Date
    February 6, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 MAR 05 2007. EVALUATION SUMMARY: THE REPORTED CONDITION OF FAILURE HIGH FLOW RATE ON ALL THREE PUMP-HEAD MODULES WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THE CAUSE OF THE ACCURACY FAILURE (OVER-DELIVERY) WAS DUE TO A DEFECTIVE PUMP-HEAD MODULE "B" AND CORROSION ON CHANNELS "A" AND "C". ALL PUMP-HEAD MODULES WERE REPLACED. THE PUMP WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL.

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO CUSTOMER SERVICE A PUMP WITH A HIGH FLOW RATE ON CHANNELS "A, B, AND C." THIS EVENT OCCURRED DURING BIO-MED TESTING. 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 3 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1