Events

Safety Alert for Bloodlines in used with Integra and AK 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
    2013-01-29
  • Event Date Posted
    2013-01-29
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130129a.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 bloodlines in used with integra and ak machines the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning bloodlines, manufactured by gambro. the affected devices are identified by the following product codes: 114626, 114562, 114525, 114620, 114526, 114527, 114524, 114563, 114635, 114557, 114561, 114636, 114651, 114625, and 11462. the manufacturer has identified a potential for increased likelihood of clotting following the introduction of the new venous chamber on conventional bloodlines which are used with the integra and ak machines. the new venous chamber design may increase the likelihood of clotting due to the presence of potentially stagnant areas beside the blood flow inlet. the manufacturer has intended to re-introduce the original venous chamber in the gambro bloodlines. the re-introduction of the original design will start from the beginning of march 2013. in the interim, the manufacturer is providing additional instructions for the correct blood level setting in the new venous chamber. the manufacturer has established from reported incidents, that the potential for clotting is influenced by the blood level in the venous chamber and anticoagulant regime. the manufacturer would like to emphasize the need for anticoagulants must be determined for the specific patient by the attending physician. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con226926 if you are in possession of the product, please contact your supplier for necessary actions. posted on 29 january 2013.

Device

Bloodlines in used with Integra and AK machines
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Gambro Bloodlines in used with Integra and AK machines
  • Manufacturer
    Gambro

Manufacturer

Gambro