Events

Field Safety Notices about Artis/Evosys dialysis systems

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Baxter International, Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    Baxter healthcare corporation (to be adapted locally) is issuing a device correction for specific models of the artis/evosys dialysis systems in order to update the current software versions to new software versions. the current version allows for the possibility of resetting and continuing patient treatment without following the instructions for addressing alarm #642, “arterial chamber: level adjustment required.” this will subsequently deactivate the alarm for the remaining treatment time. the new software versions prevent the possibility of continuing the treatment without following the instructions for addressing alarm #642, as written in the operator’s manual. .

Device

Artis/Evosys dialysis systems

Manufacturer

Baxter International, Inc.