Syringe pumps – required user actions in the event of PL3 alarm to prevent risk of interrupted infusion

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

Action by

All users of affected devices.

Deadlines for actions

Actions underway: 22 January 2018

Actions complete: 23 April 2018

Device details

AlarisTM, AsenaTM GS, GH, CC, TIVA, PK Syringe pumps manufactured before 2008.

Product codes with prefix: 8001, 8002, 8003, 8004, 8005

Manufacturer contact details

BD/Carefusion
Tel: 0800 917 8776

Email: UK-Customer-service@bd.com

Distribution

If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.

Trusts (NHS boards in Scotland)

CAS and NICAS liaison officers for onward distribution to all relevant staff including:

  • A&E consultants
  • A&E departments
  • A&E nurses
  • Adult intensive care units
  • All departments
  • All wards
  • Ambulance services directors
  • Ambulance staff
  • Anaesthesia, directors of
  • Anaesthetic medical staff
  • Anaesthetic nursing staff
  • Anaesthetists
  • Anti-coagulation clinics
  • Cardiac laboratory technicians
  • Cardiologists
  • Cardiology departments
  • Cardiology nurses
  • Cardiothoracic departments
  • Cardiothoracic surgeons
  • Clinical perfusionists
  • Community hospitals
  • Community nurses
  • Coronary care departments
  • Coronary care nurses
  • Day surgery units
  • District nurses
  • EBME departments
  • Endocrinology units
  • ENT departments
  • ENT medical staff
  • Equipment stores
  • Equipment libraries and stores
  • Gastroenterology departments
  • Gastro-intestinal surgeons
  • General surgeons
  • General surgery
  • General surgical units, directors of
  • Gynaecologists
  • Gynaecology departments
  • Gynaecology nurses
  • Haematologists
  • Haemodialysis nurses
  • Haemodialysis units
  • Health and safety managers
  • Hospital at home units
  • In-house maintenance staff
  • Intensive care medical staff/paediatrics
  • Intensive care nursing staff (adult)
  • Intensive care nursing staff (paediatric)
  • Intensive care units
  • Intensive care, directors of
  • IV nurse specialists
  • Maintenance staff
  • Minor injury units
  • Maternity units
  • Maxillofacial departments
  • Medical directors
  • Medical libraries
  • Medical oncologists
  • Neonatal nurse specialists
  • Neonatology departments
  • Obstetricians
  • Obstetrics and gynaecology departments
  • Obstetrics departments
  • Obstetrics nurses
  • Oncology nurse specialists
  • Operating department practitioners
  • Oral surgeons
  • Orthopaedic surgeons
  • Outpatient theatre managers
  • Outpatient theatre nurses
  • Paediatric intensive care units
  • Paediatric nurse specialists
  • Paediatric oncologists
  • Paediatric surgeons
  • Paediatric surgery, directors of
  • Paediatric wards
  • Paediatricians
  • Paediatrics departments
  • Palliative care teams
  • Paramedics
  • Patient transport managers
  • Peritoneal dialysis units
  • Purchasing managers
  • Renal medicine departments
  • Renal medicine, directors of
  • Risk managers
  • Special care baby units
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatres
  • Urology departments

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only) Care homes providing nursing care (adults)

  • Hospices
  • Hospitals in the independent sector
  • Independent treatment centres
  • Nursing agencies
  • Private medical practitioners

Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2017/036 or 2017/010/003/701/009.

Technical aspects

Rebecca Flint of Leanne Simpson, MHRA
Tel: 020 3080 6083 or 020 3080 7143

Rebecca.Flint@mhra.gov.uk or Leanne.Simpson@mhra.gov.uk

Clinical aspects

Devices Clinical Team, MHRA
Tel: 020 3080 7274

DCT@mhra.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

Alerts in Northern Ireland are distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety

Tel: 028 9052 3868

Email: niaic@health-ni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC)

Please report directly to NIAIC using the forms on our website.

Scotland

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland

Tel: 0131 275 7575

Email: nss.iric@nhs.net

Reporting adverse incidents in Scotland

NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.

Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.

Private facilities providing care to private clients report to the Care Inspectorate and MHRA.

Wales

Enquiries in Wales should be addressed to:

Healthcare Quality Division,
Welsh Government

Tel: 02920 823 624 / 02920 825 510

Email: Haz-Aic@wales.gsi.gov.uk

Reporting adverse incidents in Wales

Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).

Download documents

MDA/2017/036 - BD Alaris/Asena syringe pumps (specific product codes)

Published 20 December 2017