Events

Safety Alert Or Field Safety Notices for Primus anaesthetic workstation

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/2007/040
  • Event Number
    CON2031245
  • Date
    2007-05-23
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2031245
  • 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
    Potential misconnection of the backup oxygen cylinder; the oxygen cylinder inlet is situated alongside an oxygen outlet and both are fitted with the same connector.  a misconnection to the oxygen outlet would prevent backup oxygen supply in the event of oxygen pipeline failure. the use of an oxygen backup cylinder is optional on the primus.  if the backup cylinder is required the user must attach the cylinder, connect its oxygen nist fitting and connect the gas pressure sensor before use.  the primus has the further user option of an oxygen outlet, which is slightly longer and situated alongside the oxygen cylinder inlet fitting at the back of the primus.  this oxygen outlet is the same nist fitting as the oxygen inlet beside it and therefore users can connect the oxygen cylinder to the wrong fitting. the mhra has received a report of this misconnection, which was not detected in the device’s automated pre-use checks or the pre-use checks recommended by the aagbi (association of anaesthetists of great britain and ireland).  the oxygen pressure gauge indicated that the backup oxygen cylinder was full so the misconnection was not apparent to the user.
  • Action
    Ensure the backup oxygen cylinder’s NIST (non-interchangeable screw threaded) fitting is connected to the appropriate oxygen inlet.  The correct connection guide can be found above the gas inlet block at the back of the device. Users are recommended that pre-use checks should include the disconnection of the oxygen pipeline to ensure the continuity of oxygen supply from the backup cylinder.

Device

Primus anaesthetic workstation
  • Model / Serial
  • Product Description
    Primus anaesthetic workstation supplied by Draeger Medical UK Ltd. The Primus anaesthetic workstation is a modern machine with an integrated ventilator and gas monitoring system for the administration of anaesthesia to adults, children and neonates.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429