BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1023159 · Received April 3, 2008

    Report

    Report Number
    6000001-2007-00435
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    December 28, 2006
    Report Date
    December 28, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    600000-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: FAILURE CODE 810:11 WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THIS FAILURE CODE WAS CAUSED BY A WET TUBING CHANNEL. THE PUMP HEAD MODULE WAS CLEANED AND DRIED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION, FAILURE CODE 810:11 WAS FOUND IN THE PUMP'S EVENT HISTORY. 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