Events

Safety Alert for AK 200 S and AK 200 ULTRA S Nocturnal Home Hemodialysis Machines

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Gambro.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-02-06
  • Event Date Posted
    2015-02-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150206a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: gambro ak 200 s and ak 200 ultra s nocturnal home hemodialysis machines australian therapeutic goods administration (tga) posted a medical device safety alert concerning ak 200 s and ak 200 ultra s nocturnal home hemodialysis machines, manufactured by gambro. the manufacturer 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 according to the local supplier, the affected products are distributed in hong kong. for details, please refer to the following tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00093-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 february 2015.

Device

AK 200 S and AK 200 ULTRA S Nocturnal Home Hemodialysis Machines
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Gambro AK 200 S and AK 200 ULTRA S Nocturnal Home Hemodialysis Machines
  • Manufacturer
    Gambro

Manufacturer

Gambro