S3 BUBBLE SENSOR I 1/4"

Additional Manufacturer Narrative

H10: THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT BUBBLE SENSOR WAS GIVING FALSE ALARMS AND WAS SCRAPPED AFTER THE INSTALLATION OF THE NEW ONE. ROOT CAUSE OF THE REPORTED ISSUE IS TRACED BACK TO A DEFECTIVE BUBBLE SENSOR. THEREFORE, BASED ON THE INFORMATION RECEIVED, THE EVENT HAS BEEN RE-ASSESSED AS NOT REPORTABLE. IN FACT, 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.

Description of Event or Problem

SEE INITIAL REPORT.

Additional Manufacturer Narrative

PATIENT INFORMATION WAS NOT PROVIDED. LIVANOVA DEUTSCHLAND MANUFACTURES THE S3 BUBBLE DETECTOR SENSOR. THE INCIDENT OCCURRED IN 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 OF A BUBBLE SENSOR MALFUNCTION. THERE IS NO REPORT OF ANY PATIENT INJURY.