CADD® administration sets with Flow Stop free-flow protection manufactured by Smiths Medical ASD – risk of under-infusion

All devices with an expiration date on or before 31 March 2021 are at risk of under-infusing so we advise users to undertake a risk assessment before using them. (MDA/2016/006)

Action

  • Identify users of the CADD administration sets with Flow Stop and with the product re-order numbers stated in the Field Safety Notice (FSN).
  • Ensure that all healthcare users receive the manufacturer’s FSN and that they understand the problem.
  • Healthcare providers should assess the risks and benefits associated with the use of these devices for each individual patient when administering therapies where accuracy is critical e.g. cytotoxics, antibiotics and sedation.
  • If necessary, Smiths Medical can supply sets without free-flow protection as an alternative, until production levels of unaffected devices can meet demand. Contact Smiths Medical to obtain these devices.
  • Report any adverse incidents involving these devices to the MHRA.

Action by

All healthcare workers who use this device.

Deadlines for actions

Actions underway: 22 June 2016

Actions complete: 20 July 2016

Problem / background

The administration sets have the potential to under-infuse by up to 13.4% (this includes the manufacturer’s accuracy level of 6%, referenced in the CADD Ambulatory Infusion Pump Operator’s Manual). The sets are used for a variety of infusion therapies e.g. chemotherapy, sedation, cardiology, nutritional therapy etc. Therefore, the potential health consequences are varied and will depend on the patient and therapy involved.

Please see the Field Safety Notice.

Manufacturer contacts

Roche Diabetes Care Accu-Chek Pump Care Line


Telephone: 00800 76 48 47 00

Email: burgesshill.insulinpumps@roche.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 SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • A&E departments
  • A&E directors
  • 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
  • Cardiologists
  • Cardiology departments
  • Cardiology nurses
  • Cardiology, directors of
  • Cardiothoracic departments
  • Cardiothoracic surgeons
  • Cardiothoracic surgery directors
  • Clinical governance leads
  • Community children’s nurses
  • Community diabetes specialist nurses
  • Community hospitals
  • Community midwives
  • Community nurses
  • Coronary care departments
  • Coronary care nurses
  • Day surgery units
  • Diabetes clinics/outpatients
  • Diabetes nurse specialists
  • Diabetes, directors of
  • Dietetics departments
  • Dieticians
  • District nurses
  • EBME departments
  • General surgery
  • General surgical units, directors of
  • Haematologists
  • Haemodialysis nurses
  • Haemodialysis units
  • Health and safety managers
  • Hospital at home units
  • Hospital pharmacies
  • Hospital pharmacists
  • 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
  • Maternity units
  • Medical directors
  • Medical libraries
  • Medical oncologists
  • Medical oncology, directors of
  • Midwifery departments
  • Midwifery staff
  • MRI units, directors of
  • Neonatal nurse specialists
  • Neonatology departments
  • Neonatology directors
  • NHS walk-in centres
  • Nursing executive directors
  • Nutrition nurses
  • Oncology nurse specialists
  • Outpatient clinics
  • Outpatient theatre managers
  • Outpatient theatre nurses
  • Paediatric intensive care units
  • Paediatric medicine, directors of
  • 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
  • Pharmacists
  • Purchasing managers
  • Radiation & medical oncology departments
  • Radiation oncologists
  • Radiation oncology, directors of
  • Special care baby units
  • Staff supporting patients receiving haemodialysis at home
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatres
  • Urological surgeons
  • Urological surgery, directors of
  • Urology departments

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

  • Care homes providing nursing care (adults)
  • Care homes providing personal care (adults)
  • Clinics
  • Hospices
  • Hospitals in the independent sector
  • Independent treatment centres
  • 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/2016/006 or 2016/004/022/299/002.

Technical aspects

Jillan Hussein or Dr Roopa Prabhakar, MHRA

Tel: 020 3080 7148 / 7293

Email: jillan.hussein@mhra.gsi.gov.uk or roopa.prabhakar@mhra.gsi.gov.uk

Clinical aspects

Dr S Jagdish, MHRA

Tel: 020 3080 7187 Email: s.jagdish@mhra.gsi.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

Fax: 028 9052 3900

Email: NIAIC@dhsspsni.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

Fax: 0131 314 0722

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).

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MDA/2016/006 – CADD® administration sets with Flow Stop free-flow protection manufactured by Smiths Medical ASD – risk of under-infusion

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