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Originator: MHRA Medical Device Alerts

Issue date: 12-Jul-2018 14:01:36

This alert has been issued to:
  • Care Trusts
  • Mental Health Trusts
  • Specialists Trusts
  • NHS Regional Offices
  • Learning Disabilities Trusts
  • Mental Health & Social Care Trusts
  • Ambulance Trusts
  • Mental Health & Learning Disabilities Trusts
  • Acute Trusts
  • Community Trusts

  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • Social Care Providers (registered with CAS)
  • Special Health Authorities

Action category: Action

Title: All Alaris™ and Asena™ GS, GH, CC, TIVA, PK, enteral syringe pumps – risk of uncontrolled bolus of medicine.

Broadcast content:

This is a re-issue of MDA/2018/24 with amendments made under sub headings summary, action, problem/background and manufacturer contacts.

CAS LO's please close MDA/2018/24 as "action not required" and add in the free text superseded by MDA/2018/024R.

Manufactured by CareFusion, now Becton Dickinson (BD) Medical – identify and replace the back-plate in the plunger assembly and note updated preventative maintenance schedule for these pumps









Additional information: NHS England Regional Offices : Please do not cascade to primary care

Alert reference: MDA/2018/024R

Action underway deadline: 08-Aug-2018

Action complete deadline: 03-Oct-2018

Attachments:

Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency