Intra-aortic balloon pump (IABP): Maquet/Datascope CS100, CS100i and CS300 – potential for interruption or delay to therapy of critically ill patients

Manufactured by Maquet/Gettinge – a false blood detection alarm and/or fluid ingress could result in the failure of therapy to patients

Action

Note: this MDA is for a different issue to the one described in MDA/2017/027 issued 24 August 2017.

  • Identify all affected devices – see the manufacturer’s Field Safety Notice (FSN) dated 17 July 2017. Products distributed from 24 March 2003 to 16 June 2017 inclusive are affected.

  • Use an alternative IABP or an alternative therapy for treatment if available.

  • If no alternative is available, undertake a risk assessment based on a clinical risk-benefit analysis. Affected devices which remain in use should be used in accordance with the manufacturer’s FSN.

  • Contact Maquet to confirm receipt of the FSN and to schedule both the software and hardware updates to prevent false alarms and installation of gaskets to prevent fluid ingress.

Action by

All healthcare workers responsible for patients who use these devices

Deadlines for actions

Actions underway: 17 October 2017

Actions complete: 14 November 2017

Manufacturer contacts

Maquet/Getinge
Hari Rajendran
Post Market Surveillance Manager
SSU North Europe QRC/ EMEA

Tel: 0191 519 6200

hariraj.rajendran@getinge.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:

  • A&E departments
  • Adult intensive care units
  • Anaesthesia, directors of
  • Anaesthetic medical staff
  • Anaesthetic nursing staff
  • Anaesthetists
  • Cardiac laboratory technicians
  • Cardiologists
  • Cardiology departments
  • Cardiology nurses
  • Cardiology, directors of
  • Cardiothoracic departments
  • Cardiothoracic surgeons
  • Cardiothoracic surgery directors
  • Coronary care departments
  • Coronary care nurses
  • General surgical units, directors of
  • Health and safety managers
  • In-house maintenance staff
  • Intensive care units
  • Intensive care, directors of
  • Maintenance staff
  • Operating department practitioners
  • Paediatric intensive care units
  • Paediatric surgeons
  • Paediatric surgery, directors of
  • Risk managers
  • Theatre managers
  • Theatre nurses
  • Theatres

Independent distribution

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

  • Hospitals in the independent sector

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/2017/032 or 2017/007/018/291/020.

Technical aspects

Emma Rooke and Enitan Taiwo, MHRA

Tel: 020 3080 6609 or 7122

emma.rooke@mhra.gov.uk and enitan.taiwo@mhra.gov.uk

Clinical aspects

Dr Kate Antrobus, Clinical Advisor, Devices Clinical Team, MHRA

Tel: 020 3080 7274

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

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 documents

MDA/2017/032 - Intra-aortic balloon pump (IABP)

Published 3 October 2017