Events

Recall of AK 98 Self-Care Haemodialysis machine with software versions 1.1.0 and earlier

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-01415-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-11-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01415-1
  • 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
    Two software issues have been identified, as follows.1. it has been identified that the machine could become stuck in a fluid by-pass state if the operator confirms the air detector alarm during priming. in a fluid bypass state, the fluid path bypasses the dialyzer and no ultrafiltration (uf) or diffusion occurs, leading to an absence of therapy. thus, the patient may not receive the prescribed therapy when the machine gets stuck in a bypass state.2. it has been identified that the ultrafiltration supervision (ufs) may be put in an (non-functional) idle state, if the functional check of the blood module is delayed and is completed after the functional check of the fluid module. when the ufs is in a non-functional state, the machine may not be able to detect deviations in ultrafiltration during treatment. this could lead to hypovolemia or hypervolemia.
  • Action
    Baxter is advising users that a software update will be released early 2016 as a permanent fix. Baxter will contact users to arrange for the upgrade once the new software version is available. In the interim, the following instructions should be followed. 1. Make sure that the blood pump door is closed during the Function Check i.e. before “Green Fluid Path” is reached. 2. Wait to put the blood lines and the dialyser on the machine until the machine has reached Green Fluid Path.

Device

AK 98 Self-Care Haemodialysis machine with software versions 1.1.0 and earlier
  • Model / Serial
    AK 98 Self-Care Haemodialysis machine with software versions 1.1.0 and earlier Product Code: 115250Serial Numbers:11295, 10357, 10359, 10360 &10362ARTG Number: 112135
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd