BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1023113 · Received April 3, 2008

    Report

    Report Number
    6000001-2007-00211
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 11, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: FAILURE CODE 812:02 WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THIS FAILURE CODE WAS CAUSED BY A FAULTY PUMP HEAD MODULE. THE PUMP HEAD MODULE WAS REPLACED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP WITH FAILURE CODE 812:02. THIS 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 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1