The manufacturer has confirmed the Enix NX 6LR61 as an additional brand of 9V battery suitable for use in the T34 pump.
For all healthcare staff who use the pump:
- ensure checks on whether infusion is running ‘as expected’ is included as part of regular checks
- if you experience problems with the battery connections (e.g. battery movement within the battery compartment), contact your local or hospital servicing department, or CME UK, to arrange for them to adjust the battery housing connection.
For all technical staff responsible for servicing this pump:
- follow actions above
- continue to ensure that the checks on battery connectors are included as part of the regular maintenance regime, as advised in the manufacturer’s field safety notice and updated technical service manual which became available in April 2018
lf you are a home patient
- you have received this alert for information only. Your healthcare provider should be aware of this issue. However, if you experience concerns, contact your healthcare provider for further advice.
This MDA supersedes MDA/2018/010.
All technical staff responsible for servicing and healthcare staff who use the pump.
Deadlines for actions
Actions underway: 11 December 2018
Actions complete: 8 January 2019
Medical Device Safety Officers (in England)
Ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.
If your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.
National Supply Codes for the Enix NX 6LR61 battery:
|NHS Supply Chain ref (England)
||BSO PaLS ref (Northern Ireland)
The battery that was originally validated for use in the T34 pump was the Duracell (MN1604) 6LR61 9v battery.
There is a +/- 2mm tolerance in size, which is allowed within IEC Standards. However, this could result in the battery moving within its housing, leading to a possible loss of connection. In some circumstances, this may result in the pump shutting down.
CME have undertaken additional battery testing on the Enix NX 6LR61 battery. CME has stated that whichever battery is recommended, it only goes part way to solve the problem of the battery not fitting securely against the contacts in the battery compartment.
As a result, CME is planning to fit a sponge pad to the battery compartment to compensate for the +/- 2mm tolerance in size of the batteries. CME plans to have this in place in November and to inform customers via a new field safety notice.
CME Medical UK (UK Distributor), a Becton Dickinson acquired company
Mr Michael Garfitt
Tel: 01253 206700
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and NICAS liaison officers for onward distribution to all relevant staff including:
- Adult intensive care units
- Anaesthesia, directors of
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Biomedical engineering
- Clinical governance leads
- Community children’s nurses
- Community hospitals
- Community nurses
- District nurses
- EBME departments
- Equipment stores
- Equipment libraries and stores
- Hospital at home units
- In-house maintenance staff
- IV nurse specialists
- Maintenance staff
- Medical directors
- Medical libraries
- Medical oncologists
- Medical oncology, directors of
- Paediatric nurse specialists
- Paediatric oncologists
- Palliative care teams
- Purchasing managers
- Supplies managers
Public Health England
Directors for onward distribution to:
- Regional directors
- Regional leads
- Risk manager
- Safety officers
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- General practitioners
- General practice managers
- General practice nurses
Liaison officers for onward distribution to all relevant staff including:
- Care at home staff
- Care management team managers
- Community care staff
- Equipment stores
- Equipment supplies managers
- In-house residential care homes
- Loan store managers
- Loaned equipment store managers
Establishments registered with the Care Quality Commission (CQC) (England only)
- Adult placement
- Care homes providing nursing care (adults)
- Care homes providing personal care (adults)
- Further education colleges registered as care homes
- Hospitals in the independent sector
- Independent treatment centres
- Nursing agencies
- Private medical practitioners
Establishments registered with OFSTED
- Children’s services
- Educational establishments with beds for children
- Residential special schools
CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Central Alerting System (CAS) by sending an email to: firstname.lastname@example.org and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2018/035 or 2018/002/026/291/004
Roopa Prabhakar or Enitan Taiwo, MHRA
Tel: 020 3080 7293 or 7122
Email: email@example.com or firstname.lastname@example.org
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Reporting adverse incidents in England
Through Yellow Card https://yellowcard.mhra.gov.uk/
Alerts in Northern Ireland are distributed via the NICAS 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
Reporting adverse incidents in Northern Ireland
Please report directly to NIAIC using the forms on our website.
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
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.
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 https://yellowcard.mhra.gov.uk/ and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).