Total intravenous anaesthesia sets (TIVA) – risk of leakage during use
Manufactured by Global Components Medical Ltd – if propofol leaks from the check valve Luer lock connector patients could become aware during surgery (MDA/2016/021)
Action
The manufacturer is due to release updated instructions for use to include recommendations for handling the Luer lock connectors in the anaesthesia set.
Whilst waiting for this advice, please ensure that you:
- identify whether you have stocks of any of the product codes listed below
- use alternative devices if possible.
If no alternatives are available:
- contact the manufacturer to obtain advice on tightening the Luer connector in the anaesthesia set
- be vigilant over possible leakages, particularly after more than one use e.g. after multiple syringe changes.
Action by
All medical and nursing staff.
Deadlines for actions
Actions underway: 10 November 2016
Actions complete: 24 November 2016
Device details
| Product code | Description |
|---|---|
| GCM-1003 | 10 METRE TIVA MRI SET |
| GCM-223 | 3 WAY TIVA SET 2.2 METRE |
| GCM-223B | 3 WAY MULTIPLE INFUSION TIVA SET 2.2 METRE BASIC |
| GCM-253 | 3 WAY TIVA SET 2.5 METRE |
| GCM-253B | 3 WAY MULTIPLE INFUSION TIVA SET 2.5 METRE BASIC |
| GCM-303B | 3 WAY MULTIPLE INFUSION TIVA SET 3.0 METRE BASIC |
| GCM-304 | 4 WAY TIVA SET 4.0 METRE |
| GCM-SPCA | SEDATION PCA SET 2.2 METRE |
Manufacturer contacts
Global Components Medical Ltd
Tel: 01276 679394
regulatory@global-medical.co.uk
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:
- All departments
- All wards
- Anaesthesia, directors of
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Anaesthetists
- Clinical governance leads
- Coronary care nurses
- Day surgery units
- Equipment stores
- General surgeons
- General surgery
- Infection prevention and control directors
- IV nurse specialists
- Medical directors
- Nursing executive directors
- Paramedics
- Resuscitation officers and trainers
- Risk managers
- Theatres
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
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/2016/021 or 2015/010/008/601/005.
Technical aspects
Roopa Prabhakar or Helen Stidwill, MHRA
Tel: 020 3080 7293 / 7047 Email: roopa.prabhakar@mhra.gsi.gov.uk or helen.stidwill@mhra.gsi.gov.uk
Clinical aspects
Dr Camilla Fleetcroft, MHRA
Tel: 020 3080 6097 Email: camilla.fleetcroft@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
Email: niaic@health-ni.gov.uk https://www.health-ni.gov.uk/niaic
Reporting adverse incidents in Northern Ireland 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
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
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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