BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1832709 · Received September 13, 2010

    Report

    Report Number
    6000001-2007-00084
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    December 6, 2006
    Report Date
    December 6, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 CONDITION OF THE FAILED PRE-ACCURACY TEST FOR UNDER INFUSION ON CHANNEL A AND B WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THE INACCURACIES WERE CAUSED BY FAULTY PUMP HEAD MECHANISMS AND THEREFORE THE PUMP HEAD MECHANISM CHANNEL A AND B WERE REPLACED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION, THE PUMP FAILED A PRE-ACCURACY TEST FOR UNDER INFUSION ON CHANNEL A AND B. 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 3CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1