BUBBLE DETECTOR SENSOR

Description of Event or Problem

SEE INITIAL REPORT.

Additional Manufacturer Narrative

H10: THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE SENSOR REACTED EVEN THOUGH THERE WAS NO AIR BUBBLES. IN CASE OF BUBBLE SENSOR TRIGGERING FALSE BUBBLE ALARMS (OVER-SENSING ISSUE), 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. BASED ON THE ABOVE RATIONALE, THE EVENT HAS BEEN RE-ASSESSED AS NOT REPORTABLE.

Additional Manufacturer Narrative

THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA DEUTSCHLAND MANUFACTURES THE BUBBLE DETECTOR SENSOR. THE INCIDENT OCCURRED IN KURUME, JAPAN. THROUGH FOLLOW-UP COMMUNICATION WITH LIVANOVA FIELD SERVICE REPRESENTATIVE, A NEW BUBBLE DETECTOR SENSOR WILL BE SHIPPED TO THE CUSTOMER. 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 BUBBLE SENSOR DETECTOR MALFUNCTIONED DURING PRIMING. NO ADDITIONAL INFORMATION IS AVAILABLE. IT CANNOT BE EXCLUDED THAT BUBBLE SENSOR DID NOT DETECT AIR BUBBLE. THERE WAS NO PATIENT INVOLVEMENT.