Lithium-ion batteries in a medical device can cause smoke and sparks if dropped

Damaged lithium-ion batteries in a medical device have been a cause for concern for the Medicines and Healthcare products Regulatory Agency (MHRA).

The CARDIOSAVE hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE rescue IABP have been reported to have damaged lithium-ion batteries that may give off smoke, a bad smell, or produce sparks.

Macquet, the manufacturer of the medical device, has warned users to avoid carrying spare batteries when transporting the IABP to reduce the risk of dropping and damaging them.

Medical Alert

The Medical Device Alert issued on 7^th March 2017 identified the affected batteries as those with number 0146-00-0097 that were distributed from 12^th December 2011 to 9^th November 2016.

Macquet originally issued an urgent product recall on 23^rd December 2016, asking for the information to be forwarded to all current and potential CARDIOSAVE hybrid and rescue intra-aortic balloon pump (IABP) users. In the recall letter they note that they continually monitor the performance of the CARDIOSAVE IABPs and had discovered the issue that affects the lithium-ion battery. They warned that if the lithium-battery is accidentally dropped, this may cause the battery to vent.

Although the risks are contained in the warnings section of the user manual, battery venting has the capacity to create smoke, a bad smell and sparks.

Corrective action and advice

Macquet has made corrective action on the affected batteries by affixing a “Do Not Drop” label on the battery. They’ve also provided additional instructions that will assist and remind users to take extra care to avoid dropping the battery.

In addition to that, Macquet are in the process of providing a re-usable transport and storage case to transport the spare batteries in. It’s noted that the cases will be provided to users at no extra charge. They strongly advise against transporting the spare batteries until a re-usable transport and storage case is provided to them. They also recommend using an inverter and a transport AC power supply instead of carrying the spare batteries.

MHRA calls for action

The MHRA are calling for the following organisations to make the corrective actions:

• Care Trusts
• Mental Health Trusts
• Specialists Trusts
• NHS Regional Offices
• Learning Disabilities Trusts
• Mental Health & Social Care trusts
• Ambulance Trusts
• Mental Health & Learning Disabilities
• Acute Trusts
• Community Trusts

A deadline for the actions to be complete have been issued for the 7^th June 2017.

Reported issues?

The medical device manufacturer notes that there hasn’t been any reported harm or adverse effect relating to the issue and of the 8,000 lithium-ion batteries distributed worldwide thus far, but there has only been 3 reported occurrences of the battery venting when dropped.

Adverse effects and problems associated with the use of the product may be reported to the U.S. Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme, online, via mail or fax.

Sources:

https://assets.publishing.service.gov.uk/media/58be66d6ed915d6035000109/MDA_-2017-004.pdf
https://www.gov.uk/drug-device-alerts/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