Medical Device Alert: All 5008 & 5008S haemodialysis machines manufactured by Fresenius Medical Care AG & Co. KGaA (MDA/2010/053)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/053 or 2010/004/016/291/023.

Technical aspects
Roopa Prabhakar or Catriona Blake
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3293 / 3219
Fax: 020 7084 3209

Email: roopa.prabhakar@mhra.gsi.gov.uk or catriona.blake@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines & 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).

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

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

An electronic component may fail and cause the visual screen display of the haemodialysis machine to ‘black out’. The touch screen may still remain active/touch sensitive despite the visual screen failure.

Smoke may also be released from the screen.

A potential defect of an electronic component (a capacitor) on the inverter PCB within the monitor of the Fresenius 5008 and 5008S dialysis machines has been identified. The defective capacitor may cause the backlight of the screen to stop working, which may also lead to thermal overheating resulting in smoke being produced from the screen assembly of the machine. The average running hours where this has been seen to occur is 8,000 hours.

During the failure of the screen, the safety system of the dialysis machine is still active. Patients can still have their full circuit blood returned and be safely disconnected from bloodlines and the machine (see Appendix for an extract from the instructions for use).

The manufacturer is aware of this failure mode and has started to replace affected inverter boards, with completion due in September 2010. However, a Field Safety Notice has not been issued to users. Therefore, this alert has been issued to ensure users are aware of the problem.

Ensure that all users and relevant service staff for these machines are aware that this failure can cause the screen to ‘black out’ and smoke to be emitted from the screen, which may cause distress to users/patients.

Contact Fresenius Medical Care if you have not yet received upgraded inverter printed circuit boards (PCB). Local service agents will be able to install these boards, when available.

Until the part is upgraded ensure that users are:

• familiar with the appended procedure for handling the machine in the event of a visual screen display failure/blank screen occurrence
• aware that, although the visual screen display has failed, the screen may still be operational ie is still touch sensitive. Therefore the machine may still respond to any contact with the screen, which may result in the machine being activated inadvertently.

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:

• Adult intensive care units
• Biomedical engineering staff
• EBME departments
• Fire officers
• Haemodialysis nurses
• Haemodialysis units
• Health and safety managers
• In-house maintenance staff
• Maintenance staff
• Medical directors
• Nursing executive directors
• Renal medicine departments
• Renal medicine, directors of
• Renal technicians
• Renal units
• Risk managers
• Satellite renal units
• Staff supporting patients receiving haemodialysis at home

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

• Hospitals in the independent sector
• Independent dialysis centres

Tony Newsham
Fresenius Medical Care Ltd
Nunn Brook Road
Huthwaite
Sutton in Ashfield
NG17 2HU

Tel: 01623 445 171
Fax: 01623 552 409

Email: Tony.Newsham@fmc-ag.com

Fresenius 5008 Operating Manual - Procedure for handling machine in event of screen failure (dark screen/distorted display).