BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1160127 · Received September 16, 2008

    Report

    Report Number
    6000001-2007-01434
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    December 14, 2006
    Report Date
    December 14, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CONDITION OF PUMP THAT FAILED AN ACCURACY TEST FOR UNDER INFUSION WAS CONFIRMED DURING PRODUCT EVALUATION. INSPECTION OF THE DEVICE FOUND THAT THE UNDER INFUSION WAS CAUSED BY A FAULTY PUMP HEAD MECHANISM AND THEREFORE THE PUMP HEAD MECHANISM WAS REPLACED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION, THE PUMP FAILED AN ACCURACY TEST. 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