Events

Safety Alert Or Field Safety Notices for Protect-A-Line extension set

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 Vygon.

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/2013/056
  • Event Number
    CON297509
  • Date
    2013-07-25
  • Event Date Posted
    2013-07-25
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON297509?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 false occlusion alarms and interruption to therapy. this is due to a new anti-syphon valve supplied with the sets, which has a higher opening pressure and may require adjustment of infusion pump occlusion alarm settings to avoid false occlusion alarms. vygon are validating a further modification to the anti-syphon valves to marginally reduce the required opening pressure and will supply sets incorporating these once verification has been completed.
  • Action
    Ensure that all members of staff are made aware of the recommended actions in the manufacturer’s Field Safety Notice. As some hospitals may be using both types of anti-syphon valve, be vigilant if you alter your infusion pump occlusion alarm settings for the new valves.  Make sure you do not have the previous design of valve (which operates at a lower opening pressure) on the line. The product codes for these previous devices are: 0832.01R, 0832.04R and 0832.211R.

Device

Protect-A-Line extension set
  • Model / Serial
  • Product Description
    Protect-A-Line extension set. Product codes: 0832.01, 0832.04 and 0832.211. NHS Supply Chain codes (England only): FSB128, FSB124 and FSB0146.
  • Manufacturer
    Vygon

Manufacturer

Vygon