Field Safety Notice Arrow Intra-Aortic Balloon Pumps Potential Short Battery Run Times (ICN 2134)

Alert:

• Arrow International LLC, a subsidiary of Teleflex Incorporated, has initiated a precautionary Field Safety Corrective Action (FSCA) for the Arrow AutoCat 2 and AC3 Optimus intra-aortic balloon pumps due to a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
• These IABP devices can be powered either by connecting to an AC power source or with battery power for mobile use.
• When operating the IABP device using battery power, the expected duration of pumping, after a full charge, is 90 minutes. However, Teleflex has received complaints reporting that some users of the affected IABP devices are experiencing short battery run times, including loss of power during use.
• The IABP is designed with alarms to indicate that there are 20, 10, and 5 minutes of battery life remaining.
• In the past two years Teleflex has received one complaint reporting that the unit shut off without the time remaining alarms and thirteen complaints reporting missing alarms, where the time remaining was reported to be inaccurate based on how quickly the battery was depleting.
• The immediate health consequences of battery failure are the cessation of intra-aortic balloon counter-pulsation with a potentially life-threatening reduction in cardiac output, which if left untreated, could result in death.
• As of 21 March 2023, no patient injuries or deaths have been reported.

Products Affected:

•  One of the products affected is available from NHS Supply Chain:

• Please note the product is not being removed; you may continue to use the products in the scope of this advisory notice in accordance with the mitigation actions listed.

Next Steps:

• Read and follow all the instructions in the Field Safety Notice including the actions to take to reduce the risk of short battery run time, the immediate actions to take should an IABP battery fail, and battery load testing intervals.
• Share with all relevant personnel in your organisation including as minimum personnel in the following departments: Coronary Care Unit, Interventional Cardiology Department, Cardiac Catheter Lab, Anaesthetic Department, Intensive Care Departments (Adult, Paediatric, Neonatal), Critical Care Department, Emergency Department, Vascular Access Service, Operating Room/Service, Surgical Department, Resident Training Department, and Biomedical Engineering Department.
• Complete and return the Acknowledgment Form (appendix 1 of the Field Safety Notice) and return by email to Teleflex Customer Service: uk@teleflex.com
• Should you require any further information or support concerning this issue, please contact Teleflex Customer Service via email, telephone, or fax Customer Service contact Cliodhna Coffey Telephone: +44 (0) 1494 532761 or by email: uk@teleflex.com

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor

Please be aware that in the event of a Field Safety/ Corrective Advisory Notice, we may need to provide manufacturers, UK responsible persons and distributors with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.