SORIN S3 BUBB DETECTOR

Additional Manufacturer Narrative

A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE SORIN S3 BUBBLE DETECTOR. THE INCIDENT OCCURRED IN UNITED STATES OF AMERICA. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, BUBBLE SENSOR FAILED. THERE IS NO REPORT OF ANY PATIENT INJURY.

Additional Manufacturer Narrative

H10: THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE ISSUE CLAIMED WAS RELATED TO AN OVER-SENSING GENERATING FALSE ALARMS. IN CASE OF BUBBLE SENSOR TRIGGERING FALSE BUBBLE ALARMS, THE PUMP IS STOPPED BY THE BUBBLE ALARM EVEN IF NO AIR IS PRESENT IN THE MONITORED LINE. IN SUCH SITUATIONS, THE ALARM CAN ALWAYS BE CLEARED/OVERRIDDEN BY USER, ONCE THE LINE IS VERIFIED TO BE FREE OF AIR, AND THE PERFUSION CAN BE EASILY RESTARTED. THUS, IT IS UNLIKELY THAT A FALSE BUBBLE ALARM WILL RESULT IN SERIOUS INJURY. THEREFORE, THE EVENT IS BEING RE-ASSESSED AS NOT REPORTABLE. A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE: BUBBLE SENSOR ALARM WAS REPRODUCIBLE. IN ORDER TO SOLVE THE ISSUE, THE AFFECTED BUBBLE SENSOR WAS REPLACED WITH A NEW ONE. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. COMPLAINT DATABASE REVIEW REVEALED NO FURTHER SIMILAR ISSUES SINCE UNIT INSTALLATION IN 2014. THE ISSUE WAS RELATED TO SILICONE OIL DIFFUSION THROUGH BUBBLE SENSOR CUSHIONS CAUSING FALSE ALARMS. THE RISK OF FAILURE HAS BEEN DETERMINED AS ACCEPTABLE.

Description of Event or Problem

SEE INITIAL REPORT.