Events

Safety Alert Or Field Safety Notices for enFlow® IV fluid and blood warmer

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 Vyaire.

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
  • Date
    2019-03-19
  • Event Date Posted
    2019-03-19
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/enflow-iv-fluid-and-blood-warmer-risk-of-unsafe-levels-of-aluminium-leaching-from-the-device-updated-safety-advice-from-manufacturer-mda-2019-016
  • 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
    This MDA replaces MDA/2019/015.The manufacturer has provided MHRA with additional evidence that suggests using the enFlow system with lactated Ringer’s, platelets, plasma, whole blood, packed red blood cells and Sterofundin may lead to a risk of administering potentially harmful concentrations of aluminium.
    Following comprehensive and continuing investigation by MHRA, we recommend measures are put in place to source alternative fluid warming devices as soon as possible. If no alternative devices are available in the short term, overriding clinical need for fluid warming should take precedence over considerations of risk of aluminum release.
    MHRA continues to investigate whether other devices on the market also release higher than recommended levels of aluminium and will take action where necessary.
  • Reason
    Manufactured by vyaire – cartridges with an aluminium warming plate in the fluid pathway can lead to an iv infusion containing aluminium above currently recommended safe levels.
  • Action
    Use an alternative fluid warming device if available. If alternatives are available, follow the instructions in the manufacturer’s updated Field Safety Notice. In the short term, if no alternative is available, carry out and document a local risk assessment based on a clinical risk-benefit analysis before using this fluid warmer. Overriding clinical need for fluid warming should take precedence over considerations of risk of aluminum release. Put measures in place to source alternative fluid warming systems. Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Device

enFlow® IV fluid and blood warmer
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Product Description
    The intended use of the enFlow IV Fluid/Blood Warming System is for warming blood, blood products and intravenous solutions prior to administration. It is designed to be used by healthcare professionals in the hospital, clinical and field environments to help prevent hypothermia. The system consists of the enFlow heating system and the disposable cartridge.Description Manufacturers reference NHS Supply Chain reference Blood and fluid warming unit 980105VS FSB1143 Blood and fluid warming disposable cartridges 980200EU FSB1143 Blood and fluid warming disposable cartridges with extension (30) 980202EU FSB1143
  • Manufacturer
    Vyaire

Manufacturer

Vyaire
  • Manufacturer Address
    Vyaire Medical 26125 North Riverwoods Blvd. Mettawa 60045 USATelephone +1 833 327 3284Email Bob.Arnott@vyaire.com
  • Manufacturer Parent Company (2017)
    Vyaire Holding Company
  • Source
    MHRA