Events

Safety Alert Or Field Safety Notices for Alaris® GP volumetric pump

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 CareFusion.

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/2013/017
  • Event Number
    CON254808
  • Date
    2013-03-26
  • Event Date Posted
    2013-03-26
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON254808?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 embolism. the pump produces small air bubbles (less than 50μl) which are too small to trigger either the 50-500μl air-in-line alarm set by the user, or the 1ml over a rolling 15 minutes alarm.
  • Action
    Identify affected devices. Ensure members of staff are aware of the advice detailed in the manufacturer’s Field Safety Notice. In particular, CareFusion recommends the use of an air venting filter on the infusion set for the following patient groups: patients with atrial septal defects* neonates where multiple infusions are being administered simultaneously. Where a filter cannot be used, consider using an anti-siphon valve on the infusion set. Be aware of additional advice issued by CareFusion – see appendix. * up to 20% of the population may have patent foramen ovale, which may be undetected.

Device

Alaris® GP volumetric pump
  • Model / Serial
  • Product Description
    Infusion pump: Alaris® GP volumetric pump Product refs: 80063UN01, 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G All serial numbers are affected.
  • Manufacturer
    CareFusion

Manufacturer

CareFusion