Events

Safety Alert Or Field Safety Notices for All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, 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 CareFusion/BD Medical.

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
    2017-04-12
  • Event Date Posted
    2017-04-12
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/all-alaris-gs-gh-cc-tiva-pk-enteral-syringe-pumps-and-asena-gs-gh-cc-tiva-pk-syringe-pumps-risk-of-uncontrolled-bolus-of-medicine
  • 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 carefusion/bd medical – identify and replace broken backplate spring in the plunger assembly and note updated preventative maintenance schedule for these pumps.
  • Action
    Identify all devices with the product codes listed in the FSN Ensure hospital or Carefusion service specialist checks pumps as detailed in the FSN Prioritise devices used in paediatric/neonatal/critical care areas and all devices more than three years old Ensure hospital or CareFusion replace broken springs Ensure all syringe pumps are regularly maintained and serviced in accordance with the manufacturer’s updated preventative maintenance Note that this alert replaces MDA/2017/003, which we published in February 2017

Device

All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, Syring...
  • Model / Serial
  • Product Description
    Product Name: Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pump Product codes with prefix (all variants): 8001, 8002, 8003, 8004, 8005, 8007Product Name: Asena™ GS, GH, CC, TIVA, PK Syringe Pumps Product codes with prefix (all variants): 8001, 8002, 8003, 8004, 8005
  • Manufacturer
    CareFusion/BD Medical

Manufacturer

CareFusion/BD Medical
  • Manufacturer Address
    CareFusionTel: 0800 917 8776Email: UK-customer-service@carefusion.com
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    MHRA