Field Safety Notices about Omnifuse and Omnifuse PCA Syringe Pumps

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Smiths Medical International.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Extra notes in the data
  • Reason
    The omnifuse and omnifuse pca pumps may alarm and stop delivery of infusion due to significant vibration when transporting the pumps.
  • Action
    1. Ensure that the relevant personnel in your organisation are made aware of this issue.  2. Follow the recommendations as outlined by the manufacturer in the field  safety notice attached and confirm acknowledgement of receipt of the field  safety notice to the manufacturer.  3. If you have any concerns or queries relating to this issue please contact the  manufacturer using the contact details below.