Medical Device Alert: All chest drains when used with high-flow, low-vacuum suction systems (wall mounted) (MDA/2010/040)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/040 or 2009/002/012/291/005.

Technical aspects
Ainsley Wickens or Catriona Blake
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3273
Fax: 020 7084 3219

Email: ainsley.wickens@mhra.gsi.gov.uk or catriona.blake@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3128
Fax: 020 7084 3111

Email: jonathan.plumb@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices.
Further information about CAS can be found on the Central Alerting System website (external link).

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

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

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald
BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).

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

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland - Incident Reporting and Investigation Centre (external link).

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

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

Direct connection between the chest drain bottle and the wall mounted, high-flow, low vacuum regulator without an intermediate jar or canister can lead to:

• patient injury
• loss of effective suction
• contamination of the hospital vacuum system and infection hazard.

The MHRA received a report where a patient with a chest drain, which was under active suction, sustained a tension pneumothorax. It was discovered that the high-flow, low-vacuum suction regulator attached to the hospital vacuum system had been directly attached to the patient's chest drain bottle without an intermediate collection jar or canister. Fluid in the form of froth from the chest drain bottle had entered the regulator and the safety valve had closed to prevent contamination of the hospital vacuum pipe work. Suction ceased and this effectively 'clamped' the chest drain preventing air or fluid from draining from the chest.

• Include an intermediate collection jar or canister in the suction system between the chest drain bottle and the regulator (see diagram).
• Change the intermediate collection jar or canister if it becomes contaminated with fluid or froth.
• Ensure that all users are aware of the advice on the use of suction systems given in MDA/2005/035 (issued 23 June 2005), including the recommendation that all users must receive adequate training and regular refresher training.

Line diagram of suction system including the essential intermediate collection jar or canister

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• NHS boards and trusts in Wales (Chief Executives)
• Primary care trusts in England (Chief Executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• A&E departments
• adult intensive care units
• all wards
• anaesthetists
• biomedical engineering staff
• biomedical science departments
• cardiologists
• cardiology nurses
• cardiothoracic surgeons
• clinical governance leads
• EBME departments
• estates departments
• general surgeons
• health and safety managers
• infection control nurses
• infection prevention and control directors
• maintenance staff
• medical physics departments
• microbiologists
• paediatric intensive care departments
• purchasing managers
• risk managers
• sterile services departments
• supplies managers
• theatre managers
• theatres

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

• hospices
• hospitals in the independent sector
• independent treatment centres
• nursing agencies
• private medical practitioners

Primary care trusts to:
CAS liaison officers for onward distribution to all relevant staff including:

• community hospitals
• walk-in centres