Solus Flexible Wire Reinforced Laryngeal Mask Airway – risk of hypoxia due to partial or total occlusion of the airway tube after inflating the cuff

Manufactured by Intersurgical – due to a manufacturing fault, inflation of the cuff may reduce the airway tube cross-section, leading to partial or total occlusion of the airway and reduced air flow to the patient.

Action

  • Identify affected devices (see below) and stop using them.
  • Quarantine and destroy all affected devices in stock.
  • Contact Intersurgical to acknowledge receipt of the Field Safety Notice (dated 28 March 2017) even if you don’t have affected devices left in stock.

Action by

All healthcare professionals involved in the use of these devices.

Deadlines for actions

Actions underway: 16 June 2017

Actions complete: 23 June 2017

Device details

The following models and LOT numbers are affected:

  • Solus Flexible, small paediatric, wire-reinforced laryngeal mask airway 2
  • Solus Flexible, large paediatric, wire-reinforced laryngeal mask airway 2.5
  • Solus Flexible, small adult, wire-reinforced laryngeal mask airway 3
  • Solus Flexible, medium adult, wire-reinforced laryngeal mask airway 4
  • Solus Flexible, large adult, wire-reinforced laryngeal mask airway 5

LOT numbers: from 31310139 to 31703855 inclusive.

REF numbers NHS Supply Chain Codes Scottish NDC Codes
8002001 FDD1640 n/a
8025001 FDD1641 n/a
8003001 FDD1642 NDC SKU 057290
8004001 FDD1643 NDC SKU 057306
8005001 FDD1644 n/a

Manufacturer contacts

Intersurgical Ltd
Telephone: 0118 9656 300
Fax: 0118 9656 356

Email: info@intersurgical.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 departments
  • Adult intensive care units
  • Ambulance services directors
  • Ambulance staff
  • Anaesthesia, directors of
  • Anaesthetic medical staff
  • Anaesthetic nursing staff
  • Anaesthetists
  • Community hospitals
  • Day surgery units
  • EBME departments
  • Equipment stores
  • General surgical units, directors of
  • Health and safety managers
  • Intensive care medical staff/paediatrics
  • Intensive care nursing staff (adult)
  • Intensive care nursing staff (paediatric)
  • Intensive care units
  • Medical directors
  • Paediatric intensive care units
  • Paramedics
  • Resuscitation officers and trainers
  • Risk managers
  • Theatre managers
  • Theatres

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

  • Hospitals in the independent sector
  • Independent treatment centres

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/2017/015 or 2017/003/028/299/021.

Technical aspects

Suleman Hussain or Emma Rooke, MHRA

Tel: 020 3080 6956 or 020 3080 6609

Email: suleman.hussain@mhra.gov.uk or emma.rooke@mhra.gov.uk

Clinical aspects

MHRA Devices Clinical Team

Tel: 020 3080 7274

Email: dct@mhra.gov.uk

Reporting adverse incidents in 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: 028 9052 3900

Email: niaic@health-ni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC)

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: 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

Tel: 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).

Download document

MDA/2017/015

Published 9 June 2017