BUBBLE SENSOR DETECTOR

Description of Event or Problem

LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A BUBBLE SENSOR DETECTOR DID NOT DETECT AIR BUBBLES. THE ISSUE OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE BUBBLE SENSOR DETECTOR. THE INCIDENT OCCURRED IN LINCOLN, NEBRASKA. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative

H10: THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT BUBBLE SENSOR BLADDERS WORN OUT. THEREFORE, IN ORDER TO SOLVE THE ISSUE, THE CUSTOMER ITSELF REPLACED THE ENTIRE BUBBLE SENSOR DETECTOR. BASED ON THE INFORMATION RECEIVED, THE ISSUE IS RELATED TO DEFLATED BLADDERS OF BUBBLE SENSOR WHICH CAN RESULT IN OVER-SENSING. 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 PATIENT SERIOUS INJURY OR DEATH. THEREFORE, THE EVENT HAS BEEN RE-ASSESSED AS NOT REPORTABLE.

Description of Event or Problem

SEE INITIAL REPORT.