CARDIOSAVE Hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE Rescue IABP – damaged lithium ion batteries may give off smoke, a bad smell or produce sparks
- Medicines and Healthcare products Regulatory Agency
- 7 March 2017
- 7 March 2017
- Alert type:
- Medical device alert
- Medical speciality:
- Anaesthetics, Cardiology, and Vascular and cardiac surgery
Manufactured by Maquet – until storage cases are available, avoid carrying spare batteries when transporting the IABP to reduce the risk of dropping and damaging them.
Identify affected batteries: they have part number 0146-00-0097 and were distributed from 12 December 2011 to 9 November 2016.
Maquet’s Field Safety Notice (FSN) advises users not to take spare batteries when transporting the IABP until they receive a re-usable transport and storage case.
Until the cases are available use an inverter and a transport AC power supply instead of carrying spare batteries.
If these power supplies are not available, carry out an individual risk assessment for the continued use of the devices with batteries whilst in transport.
Contact Maquet to acknowledge receipt of the FSN
Arrange for Maquet to provide (free of charge) warning labels to be applied to batteries and re-usable battery transport and storage cases.
All those who use these devices.
Deadlines for actions
Actions underway: 28 March 2017
Actions complete: 7 June March 2017
Hari Rajendran, Regulatory Affairs Officer,
Tel: 0191 519 6200
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
- Ambulance services directors
- Ambulance staff
- Anaesthesia, directors of
- Cardiology departments
- Cardiothoracic departments
- Clinical perfusionists
- Coronary care departments
- EBME departments
- Intensive care units
- Patient transport managers
- Resuscitation officers and trainers
- Risk managers
- Supplies managers
Public Health England
Directors for onward distribution
- Heads of health, safety and quality
- Risk manager
- Safety officers
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: firstname.lastname@example.org and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2017/004 or 2016/012/029/291/010.
Emma Rooke and Hiten Patel, MHRA
Tel: Tel: 020 3080 6609 / 020 3080 6115
MHRA Devices Clinical Team
Tel: 020 3080 7274
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
Tel: 028 9052 3868
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
Tel: 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,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Published: 7 March 2017
Issued: 7 March 2017
Alert type: Medical device alert