Events

Safety Alert for MultiFiltrate devices using software version 5.2

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Fresenius Medical Care AG & Co.

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
    2013-09-17
  • Event Date Posted
    2013-09-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130917.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: fresenius medical care multifiltrate devices using software version 5.2 the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning all multifiltrate devices using software version 5.2 manufactured by fresenius medical care ag & co. kgaa. the manufacturer has become aware of a software error when using the substitution bolus function during a continuous renal replacement therapy (crrt) treatment. in one case the substitution bolus unintentionally did not stop after 100 ml. in the worst case, a started substitution bolus is not controlled and automatically stopped by the machine and continues until manually stopped by the user. this situation can lead to severe volume overload and subsequently cause a serious health deterioration or even death. the manufacturer will provide the users with software update as soon as possible. meanwhile, users are strongly recommended to stop using the substitution bolus functionality. in case a fluid bolus is required during crrt, it is recommended that users should use the same process as applied in non-crrt treated patients, e.G. direct infusion of a suitable infusion solution. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con314890 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 september 2013.

Device

MultiFiltrate devices using software version 5.2
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Fresenius Medical Care MultiFiltrate devices using software version 5.2
  • Manufacturer
    Fresenius Medical Care AG & Co

Manufacturer

Fresenius Medical Care AG & Co