Events

Recall of Artiset HD SN HC Bloodlines (blood tubing system used for haemodialysis with Artis system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Baxter Healthcare Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01620-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-12-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01620-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Baxter healthcare has identified, during post-market surveillance activities, 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. 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. inadvertant disconnection of the bloodline from the patient access site due to an improper connection of the access line could result in serious adverse health consequences such as an air embolism and/or blood loss. baxter has received sporadic events reporting of inappropriate connections between the bloodline and the patient access site, resulting in external blood loss for the patient.
  • Action
    Baxter is providing users with additional instructions on how to properly connect and to avoid a disconnection, as follows: 1. Insert the male luer cone in the female connector. Stop upon perception of complete adherence between the two components. 2. Screw the male luer coupling nut on the female component until perception of the end stop. 3. After the connection is completed, check that the male luer coupling nut is firmly screwed. During the whole connection procedure for both arterial and venous patient lines (red and blue coupling nuts), hold and screw the male luer coupling nut only. Do not apply the screwing torque to the male luer body.

Device

Artiset HD SN HC Bloodlines (blood tubing system used for haemodialysis with Artis system)
  • Model / Serial
    Artiset HD SN HC Bloodlines (blood tubing system used for haemodialysis with Artis system)Product Code: 114533Lot Numbers: 1634 and onwardsARTG Number: 141589
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd