Events

Safety Alert for Artis/Evosys Dialysis System equipped with SW 8.15.06 and 8.33.02

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
    2015-01-14
  • Event Date Posted
    2015-01-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150114.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 artis/evosys dialysis system equipped with sw 8.15.06 and 8.33.02 medical device manufacturer, gambro, has issued a field safety notice concerning artis/evosys dialysis system equipped with sw 8.15.06 and 8.33.02. the manufacturer reminds users of the possibility that foam may be formed in the venous blood circuit when the extracorporeal circuit is primed using on-line priming. the priming volume specified in the operator’s manual and in the dialyzer instruction for use may not be sufficient to completely eliminate any air trapped in the dialyzer fibres. when this occurs, some foam may be created in the venous circuit during patient connection and during the first few minutes of treatment. the condition is visible to the operator. the potential hazard would be presence of some foam in the venous patient line. the air bubble detection system is designed to stop the blood pump when macro bubbles greater than 20 μl are detected. the presence of operator also reduces the risk of foam reaching the patient. according to the local supplier, only the artis dialysis system is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 january 2015.

Device

Artis/Evosys Dialysis System equipped with SW 8.15.06 and 8.33.02
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Gambro Artis/Evosys Dialysis System equipped with SW 8.15.06 and 8.33.02
  • Manufacturer
    Gambro

Manufacturer

Gambro