Terumo has issued an urgent medical device correction on Sarns™ Modular Perfusion System 8000: Cardioplegia Monitor, a device that displays a various parameters including cardioplegia volume tracking. According to the manufacturer, only certain serial numbers are affected by this safety alert.
The manufacturer has received 12 reports that captioned device fails to track the cardioplegia delivery volume as needed due to the loss of communication between the monitor and the cardioplegia pump. The manufacturer revealed that the immediate and long term effects of this failure are minimal and there has been no report of patient injury as result of this issue.
To correct the issue, Terumo will replace the software on all monitors in the affected devices. Affected customer will be contacted and the correction action will be completed within 12 months.
According to the local supplier, Hong Kong does not bare devices with the affected serial numbers.
If you are in possession of the affected product, please contact your supplier for necessary actions.