BUBBLE DETECTOR SENSOR

Additional Manufacturer Narrative

THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA DEUTSCHLAND MANUFACTURES THE BUBBLE DETECTOR SENSOR. THE INCIDENT OCCURRED IN ARLINGTON, TEXAS. 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 RECEIVED REPORT THAT A BUBBLE DETECTOR SENSOR MALFUNCTIONED DURING SETUP. CUSTOMER REQUESTED REPLACEMENT OF THE SENSOR. NO OTHER DETAIL WAS PROVIDED AND A REPORTABLE MALFUNCTION CANNOT BE EXCLUDED. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

LIVANOVA RECEIVED A REPORT ABOUT A BUBBLE SENSOR MALFUNCTION. NO PATIENT/USER AFFECTED. LIVANOVA FIELD SERVICE TECHNICIAN WAS DISPATCHED TO CUSTOMER FACILITY AND CONFIRMED THAT BUBBLE SENSOR CUSHIONS WERE DEFLATED. A NEW BUBBLE SENSOR WAS INSTALLED AND THE S5 WAS RELEASED AT ITS EXPECTED FUNCTIONS. THE UNIT IS INSTALLED SINCE 2016 AND AN ANALYSIS OF THE COMPLAINT DATABASE DID NOT REVEAL FURTHER EVENTS RELATED TO THIS BUBBLE SENSOR. THE ISSUE IS A KNOWN FAILURE THAT IS RELATED TO SILICONE OIL DIFFUSION THROUGH CUSHIONS CAUSING FALSE ALARMS, THAT WAS INVESTIGATED BY THE RCI 2015-15 (DEFLATED BUBBLE SENSOR CUSHIONS). INVESTIGATION REVEALED THAT THE OIL DIFFUSION THROUGH CUSHIONS IS A DESIGN PROBLEM. BASED ON AVAILABLE INFORMATION, IT CAN BE REASONABLY CONCLUDED THAT THE REPORTED ISSUE WAS ABOUT DEFLATED CUSHION LEADING TO OVERSENSING OF THE BUBBLE SENSOR. THIS ISSUE IS NOT LIKELY TO RESULT IN SERIOUS INJURY SINCE A FALSE ALARM CAN ALWAYS BE CLEARED BY THE USER ONCE THE LINE HAS BEEN VERIFIED TO BE FREE OF AIR AND PERFUSION CAN BE EASILY RESTARTED. IN ADDITION, IT IS ALSO POSSIBLE TO PERFORM OVERRIDE OF THE MONITORING FUNCTION. THEREFORE, THE EVENT IS RE-EVALUATED AS NOT REPORTABLE. THE RISK IS IN THE ACCEPTABLE REGION. NO CORRECTIVE ACTION IS DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

Description of Event or Problem

SEE INTIAL REPORT.