Events

Safety Alert for Medfusion Model 4000 Syringe Infusion Pump

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

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
    2012-08-03
  • Event Date Posted
    2012-08-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120803.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: smiths medical medfusion model 4000 syringe infusion pump the united states food and drug administration (fda) has issued a class i recall concerning all medfusion model 4000 syringe infusion pumps with software versions v1.0 and v1.1 manufactured by smiths medical asd, inc. according to the fda, systems errors can cause the medfusion 4000 infusion pump to go into an alarm condition and stop running, which can result in a delay or an interruption of patient therapy. for patient receiving critical therapy, a delay or interruption of therapy could result in serious injury and/or death. for details, please refer to fda website http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ ucm314282.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 3 august 2012.

Device

Medfusion Model 4000 Syringe Infusion Pump

Manufacturer

Smiths Medical ASD