BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1023941 · Received April 4, 2008

    Report

    Report Number
    6000001-2007-03515
    Event Type
    Malfunction
    Date Received
    April 4, 2008
    Date of Event
    January 9, 2007
    Report Date
    January 9, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY:THE CONDITION OF FAILING FOR ACCURACY (UNDER-INFUSION) WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THE CAUSE OF THE ACCURACY FAILURE WAS DUE TO A FAULTY PUMP HEAD MODULE. THE PUMP HEAD MODULE WAS REPLACED. THE DEVICE WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION, THE PUMP FAILED FOR ACCURACY. 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