BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1023894 · Received April 4, 2008

    Report

    Report Number
    6000001-2007-00891
    Event Type
    Malfunction
    Date Received
    April 4, 2008
    Date of Event
    January 5, 2007
    Report Date
    January 5, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE INFUSION PUMP WAS TESTED FOR FLOW ACCURACY AT 100 ML/HOUR, THE INFUSION PUMP FAILED THE ACCURACY TEST. THE SPECIFICATION OF THIS DEVICE IS +/-5%. THE PUMP HEAD MODULE WAS REPLACED.

    Description of Event or Problem · 1

    THE FACILITY RETURNED THE DEVICE FOR SERVICE. DURING SERVICE THE BAXTER REPAIR TECHNICIAN NOTED THAT CHANNEL B UNDER INFUSED DURING ACCURACY TESTING. THE HOSPITAL REP STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INCIDENT INVOLVING THIS PUMP. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1