Events

Safety Alert for Ultrafilter U9000

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
    2014-08-05
  • Event Date Posted
    2014-08-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140805.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 ultrafilter u9000 medical device manufacturer, gambro, has issued a field safety notice (fsn) concerning its ultrafilter u9000. there is a possibility of external fluid leakage with ultrafilter u9000 as a result of multiple disinfections using a sodium carbonate-based solution. the housing of the ultrafilter u9000 is made of polycarbonate, a material that is known to undergo slow chemical degradation during long term exposure to alkaline substances. intensive use of sodium carbonate-based disinfection programs over several months may, therefore, 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 a leakage is observed during treatment, the user should immediately stop the treatment and change the u9000 ultrafilter to avoid excessive fluid removal from the patient. furthermore, the use of sodium carbonate-based disinfection programmes has been broadly validated for the u9000 ultrafilter. however, to minimize the risk of an external fluid leak, the manufacturer strongly recommends adhering to the instructions mentioned in the fsn, when using sodium carbonate based disinfection programmes with u9000. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 5 aug 2014.

Device

Ultrafilter U9000
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Gambro Ultrafilter U9000
  • Manufacturer
    Gambro

Manufacturer

Gambro