Ambulatory syringe pumps (T34 and T60) and syringe extension sets used with the T34 pump, manufactured by Caesarea Medical Electronics (CME).
- Medicines and Healthcare products Regulatory Agency
- 2 March 2016
- 2 March 2016
- Alert type:
- Medical device alert
- Medical speciality:
- Critical care
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)
- 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.
- 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.
All healthcare workers and patients who use these devices.
Deadlines for actions
Actions underway: 23 March 2016 Actions complete: 08 April 2016
Where applicable, Devolved Administrations have provided supply chain codes:
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.
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.
Caesarea Medical Electronics Ltd
Telephone: 01253 206 700
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:
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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: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2016/002 or 2015/010/026/291/006
Enitan Taiwo and Jenifer Hannon
Telephone: 020 3080 7122 / 7153
Mark Grumbridge, MHRA
Senior Clinical Advisor
Telephone: 020 3080 7128
Reporting adverse incidents in England
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
Department of Health, Social Services and Public Safety
Telephone: 028 9052 3868
Fax: 028 9052 3900
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
Telephone: 0131 275 7575
Fax: 0131 314 0722
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.
Enquiries in Wales should be addressed to:
Healthcare Quality Division
Telephone: 02920 823 624/02920 825 510
Reporting adverse incidents in Wales
Published: 2 March 2016
Issued: 2 March 2016
Alert type: Medical device alert
Medical speciality: Critical care