All models of T34 ambulatory syringe pumps – updated cleaning advice and maintenance requirements due to the risk of fluid ingress (MDA/2019/030)
Manufactured by CME (a BD company) – function may be affected by fluid getting into the pump and building up over time because of specific cleaning and disinfection practices.
Action
Have systems in place to ensure:
- healthcare staff are made aware of the updated cleaning advice (Appendix 1 of the manufacturer’s Field Safety Notice) and that this is added to the instructions for use for this product
- healthcare staff know that they need to check regularly that an infusion is running as expected and to follow troubleshooting advice in the instructions for use. If you can’t resolve a problem, contact the technical staff in your organisation or the manufacturer for help
- technical staff are made aware of the updated technical bulletin (Appendix 2 of the FSN) and that this is added to the technical service manual
- reporting of any incidents or complaints involving this product to BD/CME, to your local incident reporting system and/or the national incident reporting authority as appropriate Yellow Card Scheme in England or the appropriate authority in Scotland, Northern Ireland and Wales
Action by
All technical staff responsible for servicing these devices and healthcare staff who use these pumps.
Deadlines for actions
Actions underway: 31 October 2019
Actions complete: 11 December 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.
Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.
Problem/background
BD/CME has published a field safety notice (FSN), which includes revised ‘manufacturer recommended cleaning’ instructions and an updated technical bulletin.
The manufacturer has also produced guidance steps to identify whether additional action is required for the pump in Appendix 3 of the FSN. MHRA is seeking further clarification regarding these actions.
Manufacturer contacts
Becton Dickinson UK Ltd.
Customer service line: 0800 917 8776 (press option 2, then option 4)
Distribution
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
- Anaesthetic medical staff
- Biomedical engineering staff
- 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
- Medical physics departments
- Oncology nurse specialists
- Paediatric nurse specialists
- Paediatric oncologists
- Palliative care teams
- Purchasing managers
- Radiation & medical oncology departments
- Supplies managers
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- General practitioners (for information only)
- General practice managers
- General practice nurses
This Medical Device Alert is being sent to GPs for information only, in circumstances where patients may seek advice about the contents of this notice. GPs need take no further action on receipt of this alert.
Social services
Liaison officers for onward distribution to all relevant staff including
- Care at home staff
- Care management team managers
- Community care staff
- Day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)
- Equipment stores
- Equipment supplies managers
- In-house residential care homes
- Loan store managers
- Loaned equipment store managers
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
- Adult placement
- Care homes providing nursing care (adults)
- Care homes providing personal care (adults)
- Clinics
- Further education colleges registered as care homes
- Hospices
- 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
Please note 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: safetyalerts@mhra.gov.uk and requesting this facility.
Enquiries
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2019/030 or 2019/008/019/487/023.
Technical aspects
Roopa Prabhakar or Emma Rooke, MHRA Tel: 020 3080 6000
Clinical aspects
Devices Clinical Team, MHRA
Tel: 020 3080 7274
To report an adverse incident involving a medical device in England use the Yellow Card reporting page.
Northern Ireland
Northern Ireland Adverse Incident Centre (NIAIC)
CMO Group
Department of Health, Social Services and Public Safety
Tel: 0208 9052 3868
To report an adverse incident involving a medical device in Northern Ireland use the forms on the website.
Alerts in Northern Ireland are distributed via the NICAS system.
Scotland
Incident Reporting and Investigation Centre (IRIC)
Health Facilities Scotland
NHS National Services Scotland
Tel: 0131 275 7575
To report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account. For more information, or if you can’t access the webform, visit the website: how to report an adverse incident.
Wales
Population Healthcare Division, Welsh Government
Tel: 03000 250986 or 03000 255510
To report an adverse incident involving a medical device in Wales, use the Yellow Card reporting page and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
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