MDA/2016/002Issued: 02 March 2016 at 14:00Valid Until: March 2017

MDA/2016/002Issued: 02 March 2016 at 14:00Valid until: March 2017

Medical Device Alert

MDA/2016/002Issued: 02 March 2016 at 14:00Valid until: March 2017

Ambulatory syringe pumps (T34 and T60) and syringe extension sets used with the T34 pump, manufactured by Caesarea Medical Electronics (CME).

Summary

CME hasrecommended the need for protection of thesepumps when exposed to direct sunlight.

In addition, due to connector leakages, the manufacturer is recallingextension sets(specific product codesand batches)used with the T34 pumps.

Action

CME has issued threeField Safety Notices for T34T60 pumps andsyringe extensionsets:

Pumps:

Identify affected devices and follow the manufacturer’s instructions in theirField Safety Notices (T34T60).
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.

Deadlinesfor 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.

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MDA/2016/002Issued: 02 March 2016 at 14:00Valid until: March 2017

Problem

Therearetwo problems covered by threeFSNs.

1)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.

2)The extension set FSN covers leakage from the connection between thefemale Luer connector and the syringe.

CME has not had sufficient confirmation that customers have received and acted on the FSNs.

Manufacturer contacts

Caesarea Medical Electronics Ltd

Tel:01253 206 700

Email:

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: 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

Tel:020 3080 7122 / 7153

Email: and

Clinical aspects

Mark Grumbridge, MHRA

Senior Clinical Advisor

Tel:020 3080 7128

Email:

Reporting adverse incidentsin England

Through Yellow Card

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

Tel:028 9052 3868

Fax:02890523900

Email:

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

Tel: 0131 275 7575

Fax:0131 314 0722

Email:

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

Tel: 02920 823624 / 02920 825 510

Email:

Reporting adverse incidentsin Wales

Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).

MHRA is a centre of the Medicines and Healthcare products Regulatory Agency, an executive agency of the Department of Health

Addressees may take copies for distribution within their own organisations

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