Ambulatory syringe pumps (T34 and T60) and syringe extension sets used with the T34 pump, manufactured by Caesarea Medical Electronics (CME).
CME has recommended the need for protection of these pumps when exposed to direct sunlight. In addition, due to connector leakages, the manufacturer is recalling extension sets (specific product codes and batches) used with the T34 pumps (MDA/2016/002)
Action
CME has issued three Field Safety Notices for T34 & T60 pumps and syringe extension sets.
Pumps:
- Identify affected devices and follow the manufacturer’s instructions in their Field Safety Notices T34 & T60.
- Contact CME to obtain a proprietary pump pouch for protection against sunlight, if required.
Extension Sets:
- Identify affected devices as described in the manufacturer’s Field Safety Notice (FSN) and quarantine them.
- Contact CME for details of alternative sets.
-
Complete and return the acknowledgment form in the FSN(s).
-
Report any adverse incidents associated with these devices to the manufacturer and MHRA.
Action by
All healthcare workers and patients who use these devices.
Deadlines for actions
Actions underway: 23 March 2016 Actions complete: 08 April 2016
Device details
Where applicable, Devolved Administrations have provided supply chain codes:
Scotland:
Contract reference: NP146/14
National Distribution Centre (NDC) item codes:
| CME extension set 100-172S | 077337 |
| CME extension set 100-172SLL | 140855 |
Please note the T34 and T60 pumps are not supplied via the NDC and, therefore, do not have an NDC supply code.
Problem
There are two problems covered by three FSNs:
-
Two FSNs cover the T34 and T60 syringe pumps which may deliver an unintended bolus and then stop infusing, when being used in direct sunlight. The same issue may occur for other T series pumps. Pouches are available from CME to protect the pump from exposure to direct sunlight.
-
The extension set FSN covers leakage from the connection between the female luer connector and the syringe.
CME has not had sufficient confirmation that customers have received and acted on the FSNs.
Manufacturer contacts
Manufacturer:
Caesarea Medical Electronics Ltd
Telephone: 01253 206 700
Email: QA@cmemedical.co.uk
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 SABS (NI) liaison officers for onward distribution to all relevant staff including:
- A&E consultants
- A&E departments
- A&E directors
- A&E nurses
- Adult intensive care units
- All departments
- All staff
- All wards
- Ambulance services directors
- Ambulance staff
- Anaesthesia, directors of
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Anaesthetists
- Cardiologists
- Cardiology departments
- Cardiology nurses
- Cardiology, directors of
- Cardiothoracic departments
- Cardiothoracic surgeons
- Cardiothoracic surgery directors
- Clinical governance leads
- Community children’s nurses
- Community hospitals
- Community nurses
- Coronary care departments
- Coronary care nurses
- Day surgery units
- District nurses
- EBME departments
- Equipment libraries and stores
- General surgery
- General surgical units, directors of
- Haemodialysis nurses
- Haemodialysis units
- Health and safety managers
- Hospital at home units
- Intensive care medical staff/paediatrics
- Intensive care nursing staff (adult)
- Intensive care nursing staff (paediatric)
- Intensive care units
- Intensive care, directors of
- Medical directors
- Medical libraries
- Midwifery departments
- Midwifery staff
- Outpatient clinics
- Outpatient theatre managers
- Outpatient theatre nurses
- Paediatric intensive care units
- Paediatric medicine, directors of
- Paediatric nurse specialists
- Paediatric oncologists
- Paediatric wards
- Paediatrics departments
- Palliative care teams
- Paramedics
- Purchasing managers
- Resuscitation officers and trainers
- Risk managers
- Supplies managers
- Theatre managers
- Theatres
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- General practitioners
- General practice managers
- General practice nurses
Social services
Liaison officers for onward distribution to all relevant staff including:
- Care at home staff
- Care management team managers
- Children’s disability services
- Community care staff
- Equipment stores
- Equipment supplies managers
- In-house domiciliary care providers (personal care services in the home)
- In-house residential care homes
- Loan store managers
- Loaned equipment store managers
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
- Nursing care (adults)
- Care homes providing personal care (adults)
- Clinics
- Domiciliary care providers
- Hospices
- Hospitals in the independent sector
- Independent treatment centres
- Nursing agencies
- Private medical practitioners
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 Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.
Enquiries
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2016/002 or 2015/010/026/291/006
Technical aspects
Enitan Taiwo and Jenifer Hannon
MHRA
Telephone: 020 3080 7122 / 7153
Email: enitan.taiwo@mhra.gsi.gov.uk or jenifer.hannon@mhra.gsi.gov.uk
Clinical aspects
Mark Grumbridge, MHRA
Senior Clinical Advisor
Telephone: 020 3080 7128
Email: mark.grumbridge@mhra.gsi.gov.uk
Reporting adverse incidents in England
Northern Ireland
Alerts in Northern Ireland are distributed via the NI SABS 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
Telephone: 028 9052 3868
Fax: 028 9052 3900
Email: NIAIC@dhsspsni.gov.uk
Northern Ireland Adverse Incident Centre (NIAIC)
Reporting adverse incidents in Northern Ireland
Please report directly to NIAIC using the forms on our 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
Telephone: 0131 275 7575
Fax: 0131 314 0722
Email: nss.iric@nhs.net
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.
Wales
Enquiries in Wales should be addressed to:
Healthcare Quality Division
Welsh Government
Telephone: 02920 823 624/02920 825 510
Email: Haz-Aic@wales.gsi.gov.uk
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
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