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Originator: MHRA Medical Device Alerts

Issue date: 29-Oct-2019 13:57:35

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
  • Acute Trusts
  • Community Trusts

  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • Ofsted recipients
  • Social Care Providers (registered with CAS)
  • Special Health Authorities
  • GP - Locum
  • GP Practices

Action category: Action

Title: Syringe driver pumps: T34™ 3rd edition models only – stop using the pump until updated instructions for use and BodyCommTM V3.0 software are released

Broadcast content: Manufactured by CME (a BD company) – the intended operation of these pumps cannot be verified due to errors in the instructions for use (IFUs) and the incompatibility with older versions of BodyComm software (88-102).

Additional information: GP Practices: please note that the content of this alert is for information only. The identification of patients who use these devices will be done at secondary care level; we are making practices aware in case patients see this information and have questions.

NHSE Regional Offices: please do not cascade this alert.

Alert reference: MDA/2019/038

Action underway deadline: 05-Nov-2019

Action complete deadline: 19-Nov-2019


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Medicines and Healthcare products Regulatory Agency