BUBBLE DETECTOR SENSOR

Additional Manufacturer Narrative

THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE BUBBLE SENSOR. THE INCIDENT OCCURRED IN (B)(6). THE BUBBLE SENSOR WAS REPLACED WITH ANOTHER. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

Description of Event or Problem

LIVANOVA RECEIVED REPORT THAT A BUBBLE SENSOR DETECTOR MALFUNCTIONED DURING PROCEDURE. THE ISSUE COULD NOT BE RESOLVED DESPITE UNPLUGGING AND PLUGGING IN THE MODULE. THE EXACT MALFUNCTION DESCRIPTION WAS NOT PROVIDED TO LIVANOVA AND A REPORTABLE MALFUNCTION CANNOT BE EXCLUDED. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

H.10: THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE BUBBLE SENSOR ALARMED EVEN IF NO AIR WAS PRESENT IN THE MONITORED LINE. REPORTABILITY DECISION CHANGES TO NOT REPORTABLE EVENT BASED ON THE ABOVE INFORMATION RECEIVED. A BUBBLE SENSOR TRIGGERING FALSE ALARMS IS ASSESSED AS NOT REPORTABLE SINCE AN OVER SENSING OF THE BUBBLE SENSOR, TRIGGERING FALSE BUBBLE ALARMS, CANNOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. INDEED, THE ALARM CAN ALWAYS BE CLEARED ONCE THE LINE HAS BEEN VERIFIED TO BE FREE OF AIR AND THE PERFUSION CAN BE EASILY RESTARTED.

Description of Event or Problem

SEE INITIAL REPORT.