Medical Device Alert: Dialysis bloodlines manufactured by BBraun Avitum AG (MDA/2009/060)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/060 or 2009/007/021/081/010.

Technical aspects
Roopa Prabhakar or Geoff Ali
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3293 / 3102
Fax: 020 7084 3209

Email: roopa.prabhakar@mhra.gsi.gov.uk or geoff.ali@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 (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast BT16 1US

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 Jane Ludlow
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff CF10 3NQ

Tel: 029 2082 3505 / 3922

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

Blood leakage at the arterial chamber (PBE chamber) junction.

BBraun has identified a manufacturing problem affecting the production of dialysis bloodlines, which may result in leakages occurring at the arterial or pressure before entry (‘PBE’) chamber. The leakage can occur during priming or during treatment.

BBraun’s instructions recommend that the PBE monitoring system must be connected at all times during treatment. Although this system will alarm and stop treatment if leakages are detected, there remains a risk of blood loss and increased risk of infection. There is also increased risk of exposure to blood for staff/carers. If the PBE system is not connected, the patient may be exposed to the risk of significant blood loss as a result of undetected blood leakage.

• Check lot numbers to identify whether you have any affected devices.
• Quarantine and do not use affected devices.
• Contact BBraun for replacements.
• If replacements are unavailable from BBraun, source sets from alternative suppliers.

Ensure that all relevant staff are notified that the PBE monitoring system should be connected during dialysis treatment as per the manufacturer’s instructions. This will ensure the machine will alarm if a defective set is inserted onto the machine. However, staff are reminded to regularly inspect the bloodlines even if the PBE system is connected as a small leak may not be detected in use.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• HSC Trusts in Northern Ireland (Chief Executives)
• NHS Boards in Scotland (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:

• Adult intensive care units
• Biomedical engineering staff
• EBME departments
• Equipment stores
• Haemodialysis nurses
• Haemodialysis units
• Renal medicine departments
• Renal medicine, directors of
• Renal technicians
• Risk managers
• Staff supporting patients receiving haemodialysis at home
• Supplies managers

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

• Hospitals in the independent sector
• Independent haemodialysis centres

Ms Catherine Clulow
BBraun Medical Ltd
Brookdale Road
Thorncliffe Park
Sheffield S35 2PW

Tel: 0114 225 9155
Fax: 0114 225 9111

Email: catherine.clulow@bbraun.com