Cook Vacuum Pump for IVF – risk of electric shock or burn to operator

Manufactured by Cook Medical – risk of electric shock or burn, and failure of the device to operate during IVF procedures because of non-compliant mains wiring.

Action

  • Identify the affected devices as stated in device details and, in the manufacturer’s, Field Safety Notice (FSN).
  • Ensure that all users receive the manufacturer’s FSN and that they understand the problem.
  • Ensure a residual current device (RCD), which is marked stating its compliance with BS 7071, is fitted to the mains electricity supply to mitigate the risk of a hazardous situation. RCDs are also known as a ground fault circuit interrupter (GFCI), ground fault interrupter (GFI), or an appliance leakage current interrupter (ALCI).
  • If you do not have access to an RCD (or equivalent) do not use the vacuum pump until the mains wiring for the unit has been replaced by the manufacturer.
  • If an adverse event occurs relating to this issue please report this to the MHRA via Yellow Card or the relevant devolved administrations (Scotland, Wales and Northern Ireland).

Action by

All technical staff responsible for servicing and healthcare staff who use the vacuum pump.

Deadlines for actions

Actions underway: 08/06/2018

Actions complete: 22/06/2018

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.

Device details

Product Name Reference Part Number Global Product Number Lot Numbers
Cook Vacuum Pump™ K-MAR-5200 G49275 All lots

Problem / background

The manufacturer identified that the internal mains wiring does not fully comply with the requirements of the medical electrical equipment standard IEC60601-1 Edition 3.0.

The potential hazardous situations which could arise as a result of this include; failure of the device to operate or electric shock or burn to the user.

Manufacturer contacts

Cook Medical
Ms. Sinead Burke

Tel: +353 (0)61 334440

Sinead.burke@CookMedical.com

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:

  • Biomedical science departments
  • Clinical governance leads
  • Clinical pathology directors
  • EBME departments
  • Gynaecology departments
  • Gynaecology nurses
  • In-house maintenance staff
  • Maintenance staff
  • Medical directors
  • Obstetrics and gynaecology departments
  • Obstetrics and gynaecology directors
  • Risk managers

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@mhra.gov.uk and requesting this facility.

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2018/017 or 2018/003/016/701/039.

Technical aspects

Zarah Naeem or Paul Sandhu, MHRA

Tel: 020 3080 6930/7266

Email: zarah.naeem@mhra.gov.uk

Email: paul.sandhu@mhra.gov.uk

Clinical aspects

Devices Clinical Team, MHRA

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 NICAS 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

Email: niaic@health-ni.gov.uk

https://www.health-ni.gov.uk/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

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 documents

Cook Vacuum Pump for IVF – risk of electric shock or burn to operator (MDA/2018/017)

Published 24 May 2018