Events

Safety Alert Or Field Safety Notices for Syringe pumps

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 BD Alaris/Asena syringe pumps.

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
    2017-12-20
  • Event Date Posted
    2017-12-20
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/syringe-pumps-required-user-actions-in-the-event-of-pl3-alarm-to-prevent-risk-of-interrupted-infusion
  • 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
    Bd alaris/asena syringe pumps (specific product codes) – internal malfunction may cause pl3 alarm to sound and the infusion to stop (mda/2017/036).
  • Action
    Identify all devices with product codes listed in the Field Safety Notice (FSN). Stop using any pump that exhibits a PL3 alarm If you have any pumps manufactured before 2008, contact BD Carefusion to arrange for repair as detailed in the technical service manual Comply with recommended preventative maintenance processes as defined in the technical service manual

Device

Syringe pumps
  • Model / Serial
  • Product Description
    AlarisTM, AsenaTM GS, GH, CC, TIVA, PK Syringe pumps manufactured before 2008.Product codes with prefix: 8001, 8002, 8003, 8004, 8005
  • Manufacturer
    BD Alaris/Asena syringe pumps

Manufacturer

BD Alaris/Asena syringe pumps
  • Manufacturer Address
    BD/Carefusion Tel: 0800 917 8776Email: UK-Customer-service@bd.com
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    MHRA