BUBBLE DETECTOR SENSOR

Additional Manufacturer Narrative

THERE WAS NO PATIENT INVOLVEMENT. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. LIVANOVA DEUTSCHLAND MANUFACTURES THE BUBBLE DETECTOR SENSOR. THE INCIDENT OCCURRED IN (B)(6). 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 S5 BUBBLE DETECTOR SENSOR WAS NOT WORKING DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

H10: THROUGH FOLLOW-UP COMMUNICATION, LIVANOVA LEARNED THAT THE S5 SYSTEM WOULD CONTINUOUSLY ALARM WHEN THE BUBBLE SENSOR WAS ENABLED. THE CUSTOMER ORDERED AND REPLACED THE BUBBLE SENSOR THEMSELVES. INITIAL REPORTABILITY DECISION CHANGES TO NOT REPORTABLE EVENT DUE TO ADDITIONAL INFORMATION RECEIVED ABOUT BUBBLE SENSOR BEING OVERSENSING. 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. H3 OTHER TEXT : THE CUSTOMER ORDERED AND REPLACED THE BUBBLE SENSOR THEMSELVES.

Description of Event or Problem

SEE INITIAL REPORT.