Hansen-type coloured dialysis fluid line connectors - incorrectly configured
(All manufacturers) potential for the red and blue Hansen type dialysis fluid line connectors to be incorrectly configured (interchanged) which results in significantly less efficient dialysis. (MDA/2010/020)
Device
Hansen type coloured connectors on dialysis fluid lines used on Dialysis and Haemodiafiltration machines.
All manufacturers.
Problem
Potential for the red and blue Hansen type dialysis fluid line connectors to be incorrectly configured (interchanged) resulting in a significantly less efficient dialysis on Dialysis.
The MHRA is aware that the colour coding of the dialysis fluid line connectors of dialysis machines can be in either of the two configurations in the table below. The configuration will depend on manufacturer and local practice in renal units. Therefore, the coloured Hansen type connectors cannot be relied on to indicate the direction of the fluid flow through the dialyser.
Dialysis fluid supply to the dialyser
- Configuration 1 connector colour: Blue
- Configuration 2 connector colour: Red
Dialysis fluid return to the dialyser
- Configuration 1 connector colour: Red
- Configuration 2 connector colour: Blue
There have been occurrences where machines in a unit (or a patient’s home) were set up with the red and blue Hansen type connectors transposed. This led to inefficient dialysis being performed until the discrepancy was discovered.
A system that uses a dialysis adequacy monitor will show an incorrect clearance value if the machine has not been set up with the dialysis fluid and blood flowing in opposite directions.
Note: the failsafe way to identify the dialysis fluid lines/correct configuration is to note that the dialysis fluid supply line is always connected to the venous side of the dialyser.
Action
Renal technologists should:
- not rely solely on the colour of the Hansen type connectors to ensure that dialysis fluid flows in the opposite direction to the blood
- check local unit policy regarding the colour configuration of dialysis fluid lines/Hansen type connectors to ensure that all machines are configured correctly and consistently within your unit
- set up systems to ensure that the same checks are undertaken on all machines used in the home care setting, and provide advice to home users on how to do this.
Distribution
This MDA has been distributed to:
- NHS trusts in England (Chief Executives)
- Care Quality Commission (CQC)
- 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
- EBME departments
- haemodialysis nurses
- haemodialysis units
- health and safety managers
- in-house maintenance staff
- medical directors
- nursing executive directors
- paediatric intensive care units
- renal medicine, directors of
- renal technicians
- renal units
- special care baby 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
Primary care trusts to:
CAS liaison officers for onward distribution to all relevant staff including:
- district nurses
Feedback
If you have any comments or feedback on this Medical Device Alert, please email us at: dts@mhra.gsi.gov.uk
England
If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/020 or 2010/001/011/081/013.
Technical aspects
Grace Walker or Roopa Prabhakar
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ
Tel: 020 7084 3397/3293
Fax: 020 7084 3209
Email: grace.walker@mhra.gsi.gov.uk or roopa.prabhakar@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 .
Northern Ireland
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 Investment Group
Room 17, Annex 6
Castle Buildings
Stormont Estate
Dundonald
Belfast
BT4 3SQ
Tel : 02890 523 704
Fax: 02890 523 900
Email: NIAIC@dhsspsni.gov.uk
Northern Ireland Adverse Incident Centre (NIAIC)
How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website .
Further information about SABS can be found on the SABS 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
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 .
Wales
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
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