BUBBLE SENSOR DETECTOR

Additional Manufacturer Narrative

A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE BUBBLE SENSOR DETECTOR. THE INCIDENT OCCURRED IN YOKOHAMA, JAPAN. LIVANOVA INITIATED AN INVESTIGATION. 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 HEATER-COOLER SYSTEM 3T CAUSED A SHORT CIRCUIT, AFTER ITS SWITCHING ON.IN DETAIL, THE BREAKER OF THE SPECIFIC SOCKET WHERE THE 3T SYSTEM WAS PLUGGED IN TRIPPED. THE DEVICE WAS THEN SWITCHED BACK ON AND THE ISSUE HAPPENED AGAIN. THERE WAS NO PATIENT INVOLVEMENT.

Description of Event or Problem

SEE INTIAL REPORT.

Additional Manufacturer Narrative

THROUGH FOLLOW-UP COMMUNICATION, LIVANOVA LEARNED THAT BUBBLE SENSOR WAS CHECKED PRIOR SURGERY AND WORKED AS EXPECTED. DURING SURGERY, AN ALARM OCCURRED AND THE SENSOR WAS CONTINUOUSLY ALARMING EVEN IF THERE WAS NO BUBBLE. BUBBLE SENSOR WAS REMOVED FROM THE TUBE AND RE-POSITIONED AND THE SITUATION DID NOT IMPROVE. MEDICAL TEAM ELECTED TO SUBSTITUTE THE SENSOR. AFTER THAT, CUSTOMER VERIFIED THE SENSOR AND INFORMED LIVANOVA THE PAD OF THE SENSOR WAS DENTED. THE SENSOR CANNOT BE REPAIRED. A DEVICE SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND IDENTIFIED THAT THE UNIT WAS MANUFACTURED IN 2018 AND NO OTHER SIMILAR EVENT HAS BEEN REPORTED, NEITHER CONCERNING TREND HAS BEEN IDENTIFIED. THE ISSUE IS A KNOWN FAILURE THAT IS RELATED TO SILICONE OIL DIFFUSION THROUGH CUSHIONS DUE TO DESIGN ISSUE AND CAUSING FALSE ALARMS. THE RISK THAT DEFLATED CUSHIONS MIGHT CAUSE PATIENT INJURY IS IMPROBABLE AND THEREFORE THE EVENT HAS BEEN REASSESSED AS NOT REPORTABLE. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.