BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 584081 · Received March 15, 2005

    Report

    Report Number
    6000001-2005-00755
    Event Type
    Malfunction
    Date Received
    March 15, 2005
    Date of Event
    February 1, 2005
    Report Date
    February 25, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FAIL CODE 810:11. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT EHE FAILURE OCCURRED DURING A PATIENT INFUSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN