BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP UK

    MDR report key: 767154 · Received November 8, 2005

    Report

    Report Number
    6000001-2005-05613
    Event Type
    Malfunction
    Date Received
    November 8, 2005
    Date of Event
    October 25, 2005
    Report Date
    October 25, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS COMPLETED ON OCTOBER 25, 2005. THE INFUSION PUMP WAS TESTED FOR FLOW ACCURACY AT 100ML/HR. THE PUMP FAILED THE ACCURACY TEST WITH A FLOW VALUE OF -5.21% BELOW THE DESIRED AMOUNT. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    BAXTER TECHNICAL SERVICES REPORTED THE PUMP WAS RETURNED FOR SERVICE WITH AN ORIGINAL REASON FOR RETURN. "CHANNEL A UNDERINFUSING AT-8.5%". NO PATIENT INJURY ASSOCIATED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA
    2
    3
    4