BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1023085 · Received April 3, 2008

    Report

    Report Number
    6000001-2007-00699
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    December 30, 2006
    Report Date
    December 30, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CONDITION OF THE PUMP HEAD MECHANISM C THAT UNDER INFUSED DURING PRODUCT EVALUATION WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THE UNDER INFUSION 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, PUMP HEAD MECHANISM C WAS UNDER INFUSING. 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