Events

Recall of AK 200 S and AK 200 ULTRA S nocturnal home hemodialysis machines

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-00093-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-02-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00093-1
  • 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 has received complaints related to a technical error in the ak 200s nocturnal home haemodialysis machines, which will stop all the pumps and close the venous clamp. this has led to 3 cases of 400ml of blood loss and a 2 day treatment delay. a further 21 reported cases resulted in a technical error and a minor treatment delay.One section in the operator’s manuals for the ak 200 s and the ak 200 ultra s instructs the user to contact technical service and to restart the blood pump to return the extracorporeal blood to the patient. restarting the blood pump is however not possible, since the venous clamp is closed and the consequence will be a blood loss for the patient.No deaths or injury have been reported as a result of this issue.
  • Action
    An addendum to the Instructions for Use is to be communicated to customers. This action has been closed-out on 03/08/2016.

Device

AK 200 S and AK 200 ULTRA S nocturnal home hemodialysis machines
  • Model / Serial
    AK 200 S and AK 200 ULTRA S nocturnal home hemodialysis machinesARTG Number: 112135
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd