BUBBLE SENSOR

Additional Manufacturer Narrative

INVESTIGATION CLARIFIED THAT THE ISSUE WAS WITH THE BUBBLE SENSOR THAT HAD DEFLATED CUSHIONS CAUSING FALSE ALARMS AND TRIGGERING ERC. BUBBLE SENSOR WAS REPLACED AND IS WORKING PROPERLY. THE ISSUE IS A KNOWN FAILURE THAT IS RELATED TO SILICONE OIL DIFFUSION THROUGH CUSHIONS CAUSING FALSE ALARMS. INVESTIGATION REVEALED THAT THE OIL DIFFUSION THROUGH CUSHIONS IS A DESIGN PROBLEM. THE RISK OF FAILURE HAS BEEN DETERMINED AS ACCEPTABLE. THERE IS NO INFORMATION THAT CAN BE PROVIDED TO DECREASE RISK BEYOND WHAT IS CURRENTLY IN THE IFU TO PERFORM AN OPERATIONAL CHECK DURING PRIMING PRIOR TO THE USE IN THE PROCEDURE AND HOW TO APPROPRIATELY RESPOND TO AN ALARM. IN CASE OF FALSE BUBBLE ALARMS (NO AIR IS PRESENT IN THE MONITORED LINE), THE PUMP IS STOPPED. 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. IT IS UNLIKELY THAT A FALSE BUBBLE ALARM WILL RESULT IN SERIOUS INJURY. THE CASE HAS BEEN REASSESSED AS NOT REPORTABLE.

Description of Event or Problem

SEE INTIAL REPORT.

Description of Event or Problem

LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT BUBBLE DETECTOR SENSOR AND ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP WERE DEFECTIVE. THE EVENT OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 ERC TUBING CLAMP. 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.