Events

Safety Alert Or Field Safety Notices for Sedana Medical AnaConDa

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 manufacturer #17429.

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/2006/045
  • Event Number
    CON2024462
  • Date
    2006-08-09
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2024462
  • 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 anaesthetic overdose. the mhra is aware of an adverse incident that occurred at the beginning of 2005 during the use of an anaconda. it is believed that the adverse event was caused by a combination of user error and inconsistencies in the instructions for use. sedana medical have taken over as the manufacturer of the anaconda and corrected these inconsistencies. the current version of the instructions for use is ifu 7 691 300-r001, published in july 2005 (available at www.Sedanamedical.Com (external link)). sedana medical is implementing changes to the design of the system to eliminate the luer connection between the syringe and the anaconda and is making additional changes to the instructions for use. sedana medical estimates that these changes will be introduced on new products at the end of 2006.
  • Action
    Check that there are procedures in place to ensure that the AnaConDa device is only used: according to the current version number of the instructions for use (At the time of publishing this is version number 9 691 300-R001, issued in July 2005) by clinicians specifically trained in the use of anaesthetic drugs with the correct level of monitoring and respiratory support, as recommended by the AAGBI (Recommendations for standards of monitoring during anaesthesia and recovery, 3rd edition, 2000).

Device

Sedana Medical AnaConDa
  • Model / Serial
  • Product Description
    Anaesthetic conserving device: Sedana Medical AnaConDa. The AnaConDa is a novel anaesthetic conserving device that can be used for administration and recirculation of Isoflurane and Sevoflurane. The AnaConDa must be used with a ventilator, a syringe pump, an anaesthetic gas monitor and a gas scavenging system.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429