Medical device manufacturer, Edwards LifeSciences, has issued a medical device safety alert concerning its ClearSight Heart Reference Sensor [Model Number: EVHRS; all serial numbers manufactured after 31 December 2015].
The current product as well as the affiliated labeling contains an expiration date of two years. Through investigation and analysis of complaint data, the manufacturer discovered that HRS units are susceptible to experiencing an "HRS Out of Range" error message in the EV1000 platform that is beyond six months from the date of manufacture. As a result, the manufacturer has decided to change the expiration date to six months from the date of manufacture.
Additionally, this change will also require replacing the Operator's Manual of the EV1000 clinical platform and the Instructions for use (IFU) of the Heart Reference Sensor.
According to the manufacturer, this issue poses no risk to patients as the EV1000 clinical platform will not allow the clinician to zero the device and initiate monitoring. This would create a pre-procedural delay while the troubleshooting process is completed.
Affected users could continue to use the product. If the user does not encounter the "HRS Out of Range" message on the EV1000 clinical platform, the Heart Reference Sensor is functioning properly and can be safely used to monitor your patients. If the user encounters the "HRS Out of Range" message on the EV1000 clinical platform, he/she should contact the manufacturer's technical support.
Product replacement is on-going.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 December 2017