BUBBLE SENSOR DETECTOR

Additional Manufacturer Narrative

THE UNIT WAS INSTALLED SINCE 2022 AND THE ANALYSIS OF THE COMPLAINTS DATABASE DID NOT REVEAL FURTHER EVENTS RELATED TO THIS BUBBLE SENSOR. LIVANOVA FIELD SERVICE TECHNICIAN REPLACED THE SENSOR WITH A NEW ONE. FROM FOLLOW UP WITH TECHNICIAN, IT EMERGED THAT THE REASON FOR CHANGING THE BUBBLE SENSOR WAS THAT THE GEL PILLOWS WERE FLAT. THE ISSUE IS A KNOWN FAILURE THAT IS RELATED TO SILICONE OIL DIFFUSION THROUGH CUSHIONS CAUSING FALSE ALARMS AND IS CAUSED BY A DESIGN PROBLEM. THE RISK OF FAILURE HAS BEEN DETERMINED AS ACCEPTABLE. THERE IS NO INFORMATION THAT CAN BE PROVIDED TO DECREASE RISK BEYOND WHAT IS CURRENTLY IN THE IFU TO PERFORM AN OPERATIONAL CHECK DURING PRIMING PRIOR TO THE USE IN THE PROCEDURE AND HOW TO APPROPRIATELY RESPOND TO AN ALARM. EVENT HAS BEEN REASSESSED AS NOT REPORTABLE SINCE 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. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

Description of Event or Problem

SEE INITIAL REPORT.

Additional Manufacturer Narrative

A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE BUBBLE SENSOR DETECTOR. THE INCIDENT OCCURRED IN DORTMUND, GERMANY. THE SENSOR WAS REPLACED BY A LIVANOVA FIELD SERVICE REPRESENTATIVE. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. 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 RECEIVED A REPORT THAT A BUBBLE SENSOR DETECTOR COULD NOT BE ACTIVATED RELIABLY, SOMETIMES NOT AT ALL. THE ISSUE OCCURRED DURING MAINTENANCE ACTIVITY. IT CANNOT BE EXCLUDED THAT BUBBLE SENSOR DID NOT DETECT AIR BUBBLE. THERE WAS NO PATIENT INVOLVEMENT.