S5 BUBBLE DETECTOR

Additional Manufacturer Narrative

LIVANOVA (B)(4) MANUFACTURES THE S5 BUBBLE DETECTOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). THE BUBBLE SENSOR AND THE BUBBLE SENSOR MODULE WERE RETURNED TO LIVANOVA (B)(4) FOR FURTHER INVESTIGATION. DURING EVALUATION, THE REPORTED ISSUE WAS CONFIRMED. THE SENSOR MODULE TESTED WITHOUT ISSUE, BUT THE BUBBLE SENSOR WAS FOUND TO HAVE DEFLATED SENSOR CUSHIONS, WHICH CAUSED THE REPORTED ISSUE. FOR SAFETY REASONS THE, BUBBLE SENSOR IS TO BE SCRAPPED. CORRECTIVE ACTIONS ARE IN PROGRESS FOR THIS TYPE OF ISSUE.

Additional Manufacturer Narrative

PATIENT INFORMATION WAS NOT PROVIDED. (B)(4) MANUFACTURES THE S5 BUBBLE DETECTOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. THE BUBBLE DETECTION SYSTEM WAS TESTED WITH THE PUMP OF THE S5 SYSTEM FOR MORE THAN 4 HOURS AND THE DEVICE FUNCTIONED AS EXPECTED WITHOUT ANY ALARM. THE MODULE SOFTWARE WAS FLASHED AND NO ISSUES WERE NOTED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

Description of Event or Problem

LIVANOVA (B)(4) RECEIVED A REPORT THAT THE S5 SYSTEM DISPLAYED AN ERROR MESSAGE THAT THE S5 BUBBLE DETECTOR AND THE BUBBLE DETECTION SYSTEM WERE DEFECTIVE DURING A PROCEDURE. THE S5 SYSTEM ALARMED AND THE PUMP CONTROLLED BY THE BUBBLES DETECTION SYSTEM STOPPED IMMEDIATELY. THE PERFUSIONIST ATTEMPTED TO OVERRIDE THE ALARM SEVERAL TIMES BUT WAS UNABLE TO DO SO AND THE CASE WAS COMPLETED WITHOUT THE BUBBLE DETECTION SYSTEM. THERE WAS NO REPORT OF PATIENT INJURY.