Events

Recall of Ultrafilter U9000 (Used on Gambro Haemodialysis Delivery Systems.)

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-2014-RN-00860-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-08-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00860-1
  • 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
    Gambro pty ltd is advising users of the potential for external fluid leakage from the ultrafilter u9000 due to multiple disinfections using a sodium carbonate-based solution. intensive use of sodium carbonate based disinfection programs over several months may cause degradation of the ultrafilter housing leading to an external fluid leakage at the position of the welding seal between the filter housing and the header cap. if the leakage is slow developing, there is a remote probability that it will not be noticed until the dialysis treatment has started.
  • Action
    If a leakage is observed during treatment, the users are advised to immediately stop the treatment and change the U9000 Ultrafilter to avoid excessive fluid removal from the patient. Gambro is advising that the use of sodium carbonate-based disinfection programs has been broadly validated for the U9000 Ultrafilter. However, to minimise the risk of an external fluid leak, Gambro recommends adhering to the following instructions, when using sodium carbonate based disinfection programs: 1. Do not exceed the recommended disinfectant concentration given in the Operator’s Manual. 2. Do not use more than eight sodium carbonate disinfection cycles over the lifetime of the U9000. 3. Do not use sodium carbonate disinfection cycles more than once a week. 4. Include daily disinfection with citric acid in the disinfection protocol. 5. Avoid periods of machine inactivity (e.g. weekend storage) directly after disinfection with sodium carbonate based agents. 6. The recommended process of combined “Heat + CleanCart-A” disinfection shall be followed by a “Heat + CleanCart-C” disinfection on the same day and ideally be performed in the middle of the working week. This action has been closed-out on 03/06/2016.

Device

Ultrafilter U9000 (Used on Gambro Haemodialysis Delivery Systems.)
  • Model / Serial
    Ultrafilter U9000 (Used on Gambro Haemodialysis Delivery Systems.)ARTG Number: 131741
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd