BUBBLE DETECTOR SENSOR

Additional Manufacturer Narrative

THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE BUBBLE SENSOR. THE INCIDENT OCCURRED IN (B)(6). 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 OF A BUBBLE DETECTOR SENSOR HAVING BUBBLE ALARM ISSUE DURING PROCEDURE. NO ADDITIONAL DETAIL WAS PROVIDED AND A REPORTABLE MALFUNCTION CANNOT BE EXCLUDED. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

PRODUCT INFORMATION HAVE BEEN UPDATED IN THE DEDICATED D.4 SECTION AS WELL AS MANUFACTURING DATE IN H.4 SECTION. H10: THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE BUBBLE SENSOR TRIGGERED FALSE ALARM. THE ALARM APPEARED EVEN IF THERE WAS NO AIR BUBBLE PRESENT IN THE LINE DUE TO DEFLATED CUSCHIONS. THE CASE HAS BEEN RE-EVALUATED AS NOT REPORTABLE SINCE AN OVER SENSING OF THE BUBBLE SENSOR, TRIGGERING FALSE BUBBLE ALARMS, CAN NOT 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. IF THE ALARMS PERSIST, THERE IS ALWAYS THE POSSIBILITY TO OVERRIDE THE ALARM, ALLOWING THE PERFUSIONIST TO START THE PUMP AGAIN.

Description of Event or Problem

SEE INITIAL REPORT.