S5 CONSOLE FOR 3 PUMP

Additional Manufacturer Narrative

A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE BUBBLE SENSOR. THE INCIDENT OCCURRED IN THE UNITED STATES OF AMERICA. 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 HAS RECEIVED A REPORT OF A BUBBLE SENSOR ERROR DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

Additional Manufacturer Narrative

H10: THROUGH FOLLOW-UP COMMUNICATION, LIVANOVA LEARNED THAT THE CUSTOMER REPLACED THE SENSOR WITH A BACK UP ONE. A DEVICE SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND IDENTIFIED THAT THE S5 CONSOLE WAS MANUFACTURED IN 2011 AND NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED SINCE ITS INSTALLATION. ACCORDING TO THE INFORMATION COLLECTED, IT IS REASONABLE TO ASSUME THAT THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT WAS A FAULTY BUBBLE SENSOR WITH THE CONTRIBUTION OF WEARING OF THE SENSOR'S ELECTRONICS. MOREOVER, THE TECHNOLOGY INCORPORATED IN THE SENSORS IS VERY DELICATE AND MAY BE DAMAGED BY IMPACT, HUMIDITY OR THERMAL STRESSES. DAMAGE DOES NOT NECESSARILY RESULT IN TOTAL FAILURE OF THE SENSOR, BUT MAY FALSIFY THE MEASURED RESULTS.

Description of Event or Problem

SEE INITIAL REPORT.