Events

Field Safety Notices about Artiset bloodline

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 is issuing a safety alert communication to inform customers of the potential for disconnection of the artiset bloodline (luer of arterial and/or venous patient connector) from the patient access site (needle/catheter) during treatment. baxter has identified a potential for increased likelihood of disconnection during post-market surveillance activities. the arterial and venous patient connectors are designed in compliance with the applicable international standards iso594 and iso8638, allowing safe connection to vascular accesses. the post-market surveillance reports of disconnection of the artiset bloodline from the patient access site were caused by the healthcare provider improperly connecting the two devices. to address this issue, baxter is providing additional instructions on how to properly connect the devices. .

Device

Artiset bloodline

Manufacturer

Baxter International, Inc.