Events

Safety Alert Or Field Safety Notices for Mains power lead used with Omnifuse syringe pumps (all models)

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Smiths Medical International Ltd.

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
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2014/044
  • Event Number
    CON478823
  • Date
    2014-11-26
  • Event Date Posted
    2014-11-26
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON478823?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
  • Reason
    Risk of interruption or delay in therapy due to incorrect design of the mains lead supplied by smiths medical. smiths medical ltd has issued a field safety notice (fsn), dated november 2014, to its customers recalling affected products but hasn’t had enough replies to know that users have received and acted on this information. the original fsn was sent in september 2014.  the manufacturer recently identified that more customers were affected and so has issued this second fsn. these 2 fsns provide the same information.
  • Action
    Ensure all personnel using these devices are aware of this FSN. Quarantine affected leads. Use an alternative pump, where available until a replacement lead is obtained. Fill in the confirmation form in the FSN and return it to the manufacturer by fax on 01582 430 001 or by  email to ukcs@smiths-medical.com

Device

Mains power lead used with Omnifuse syringe pumps (all models)
  • Model / Serial
  • Product Description
    Mains power lead used with Omnifuse syringe pumps (all models). Part number 0151-0651.
  • Manufacturer
    Smiths Medical International Ltd

Manufacturer

Smiths Medical International Ltd