Events

Recall of Artis Dialysis System equipped with SW 8.15.06 and 8.33.02

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Gambro 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-2015-RN-00057-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-01-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00057-1
  • 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
    Depending on the type of dialyzer membrane being used, excess foam may be generated in the venous circuit during patient connection and during the first few minutes of treatment. this specific condition is clearly visible to the operator.This issue was found to be primarily due to residual humidity in the fibers of the dialyzers with air permeable membranes. this problem has not been reported in dialyzers with non-air permeable membranes.None of the incidents reported resulted in a serious patient injury or medical intervention to preclude serious injury.
  • Action
    An Operator Manual Addendum is being prepared and expected to be released Q3 2015. In the interim the Customer Letter details the new instructions. This action has been closed-out on 18/07/2016.

Device

Artis Dialysis System equipped with SW 8.15.06 and 8.33.02
  • Model / Serial
    Artis Dialysis System equipped with SW 8.15.06 and 8.33.02ARTG Number: 141189
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd