Intra-aortic balloon pump (IABP): CS100, CS100i and CS300 – risk of haemodynamic instability to patients with critical conditions due to a delay in or sudden interruption of therapy

Manufactured by Datascope Corp – an electrical fault caused by a solenoid valve could mean the device fails to start or deliver therapy to patients (MDA/2017/027)

Action

  • Identify all affected devices – see the manufacturer’s Field Safety Notice (FSN) dated 19 June 2017. Only products distributed from 24 March 2003 to 11 December 2013 inclusive are affected.
  • Use an alternative IABP or an alternative therapy for treatment if available.
  • If no alternative is available, undertake a risk-benefit analysis and only use the affected device in accordance with the manufacturer’s FSN.
  • Contact Maquet to confirm receipt of the FSN and to schedule replacement of the solenoid driver board.

Action by

All healthcare professionals involved with the use of these devices.

Deadlines for actions

Actions underway: 1 September 2017

Actions complete: 15 September 2017

Manufacturer contacts

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

Telephone: 0191 519 6200

hariraj.rajendran@getinge.com

Distribution

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
  • Biomedical engineering staff
  • Biomedical science departments
  • 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/2017/027 or 2017/006/021/291/013.

Technical aspects

Suleman Hussain or Emma Rooke, MHRA

Tel: 020 3080 6956 or 020 3080 6609

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

Clinical aspects

Dr Kate Antrobus, Clinical Advisor, 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

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/2017/027 - Intra-aortic balloon pump (IABP): CS100, CS100i and CS300 – risk of haemodynamic instability to patients with critical conditions due to a delay in or sudden interruption of therapy

Published 24 August 2017
Last updated 24 August 2017 + show all updates
  1. Corrected CAS deadlines. Discard any previous versions of this MDA.
  2. First published.