Events

Safety Alert Or Field Safety Notices for Haemofiltration machine

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 Baxter.

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
    2017-07-11
  • Event Date Posted
    2017-07-11
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/haemofiltration-machine-all-prismaflex-systems-installed-with-software-version-6-10-risk-of-under-infusion-of-anticoagulant
  • 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
    Manufactured by baxter – the software fails to save the syringe type and size in service and custom modes, and so reverts to default settings.
  • Action
    Identify affected devices. Ensure that: users understand the problem detailed in the Field Safety Notice and follow the manufacturer’s advice Have systems in place to ensure the upgrade is undertaken as soon as possible or at least by the next planned annual maintenance service. Baxter will contact users to schedule the software upgrade of your devices to rectify the issue. Return the Field Safety Notice acknowledgement form to Baxter as currently the manufacturer hasn’t received enough responses.

Device

Haemofiltration machine
  • Model / Serial
  • Manufacturer
    Baxter

Manufacturer

Baxter
  • Manufacturer Address
    Pranil Patil Team Lead CQA Baxter Healthcare Ltd.Telephone: 01604 704 603uk_shs_fca@baxter.com
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    MHRA