BUBBLE SENSOR DETECTOR

Additional Manufacturer Narrative

TO FURTHER INVESTIGATE THE ISSUE ALSO THE SERIAL READ-OUT (REAL-TIME DEVICE PARAMETERS AND SETTING RECORDING FILE) OF ALL THE OTHER PUMPS USED IN THE INVOLVED SURGERY WAS ANALYZED AND NO ERROR MESSAGE RELATED TO DEVICE MALFUNCTION WAS FOUND TO BE STORED ON THE EVENT DATE. MOREOVER, THE BUBBLE SENSOR AND THE BUBBLE MODULE WERE REQUESTED BY LIVANOVA FOR INVESTIGATION. A FUNCTIONAL TEST AIMED TO VERIFY THE BUBBLE SENSOR BEHAVIOR WAS PERFORMED SIMULATING AIR BUBBLE INGRESS. A PIPE CONNECTION WAS USED TO INSERT THE BUBBLES INTO THE CIRCUIT AND PASS THEM THROUGH THE BUBBLE SENSOR. BUBBLES WERE INSERTED INTO THE CIRCUIT AT DIFFERENT FLOW VALUES (1.0, 2.0, 3.0, 5.0, 6.0, 8.0 AND 10.0 LPM) AND DIFFERENT BUBBLE SETTING THRESHOLDS (SMALL: DIAMETER OF 6.5 MM, MEDIUM: DIAMETER OF 5.0 MM AND LARGE: DIAMETER OF 4.0 MM). THE BUBBLE SENSOR CORRECTLY ALARMS AT ALL FLOW VALUES WITH THE THRESHOLD SET TO SMALL AT MEDIUM AND LARGE THRESHOLDS, THE BUBBLE SENSOR DID NOT ALARM BUT THE MICRO-BUBBLES SYMBOL WAS SHOWN ON THE BUBBLE DISPLAY OF THE SYSTEM PANEL, MEANING THAT THE SENSOR WAS ABLE TO RECOGNIZE A MICRO-AIR ACTIVITY. IN FACT, AS PER S5 INSTRUCTIONS FOR USE, THE ALARM LIMIT FOR A 3/8" BUBBLE SENSOR AT = 15 RPM DEPENDS ON THE THRESHOLD SET ON THE BUBBLE DISPLAY AND THE MINIMUM DIAMETER THE 3/8¿ BUBBLE SENSOR CAN DETECT IS 4.00 MM. POST-MARKET SURVEILLANCE ANALYSIS HAS IDENTIFIED NO SIMILAR EVENT REPORTED TO LIVANOVA. NO EVIDENCE OF THE CORRELATION BETWEEN THE INCIDENT AND THE PATIENT'S DEATH HAS BEEN PROVIDED. BASED ON GATHERED DATA, TECHNICAL SERVICE ACTIVITY AND INVESTIGATION RESULTS, NO HARDWARE FAILURE HAS BEEN DETECTED. THE POSSIBLE ROOT CAUSES OF THE REPORTED EVENT ARE THE FOLLOWING: - BUBBLE SENSOR NOT LINKED TO THE ARTERIAL PUMP OR DISABLED; - THE MICRO-BUBBLE FUNCTION AND THE RELATED ALARM TONE WERE NOT ENABLED AND THE BUBBLE DETECTED BY THE PERFUSIONIST WAS COMPATIBLE WITH A MICRO AIR ACTIVITY. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

Description of Event or Problem

SEE INITIAL REPORT.

Description of Event or Problem

LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A BUBBLE SENSOR DETECTOR DID NOT DETECT AN AIR BUBBLE, SEEN BY PERFUSIONIST IN THE ARTERIAL LINE. THE ISSUE OCCURRED DURING PROCEDURE, FOLLOWING OXYGENATOR (COMPETITOR) EXCHANGE. THE PATIENT DIED THREE (3) DAYS AFTER THE SURGERY.

Additional Manufacturer Narrative

A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE BUBBLE SENSOR DETECTOR. THE INCIDENT OCCURRED IN WIEN, AUSTRIA. THROUGH FOLLOW-UP COMMUNICATION WITH LIVANOVA FIELD SERVICE REPRESENTATIVE, IT WAS LEARNED THAT THE SURGERY STARTED ON (B)(6) 2023 AT NIGHT AND THE REPORTED ISSUE OCCURRED ON (B)(6) 2023 BETWEEN 00:40 AND 00:55 AM. THE INVOLVED UNIT HAS BEEN CHECKED BY LIVANOVA TECHNICIAN AND NO DEVIATION HAS BEEN DETECTED. THE SERIAL READ-OUT (REAL TIME DEVICE PARAMETERS AND SETTING RECORDING FILE) OF THE ARTERIAL PUMP WAS ANALYZED AND THERE IS NO DATA STORED IN THE PUMP MICROCONTROLLER ON THE DATE OF THE EVENT (B)(6) 2023), BECAUSE THE LOG FILE STARTS FROM (B)(6) 2023. MOST LIKELY THIS WAS DUE TO THE FACT THAT THE CUSTOMER CONTINUED TO USE THE DEVICE AFTER THE REPORTED EVENT AND CONSEQUENTIALLY ERROR LOG WAS OVERWRITTEN WITH NEWER DATA. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.