BUBBLE SENSOR FOR 3/8 TUBING

Description of Event or Problem

SEE INITIAL REPORT.

Additional Manufacturer Narrative

H10: THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE CORRECT SERIAL NUMBER OF THE BUBBLE SENSOR DETECTOR INVOLVED IS (B)(6). MODEL AND SERIAL NUMBER HAVE BEEN UPDATED IN THE DEDICATED D.4 SECTION. FURTHERMORE, THE AFFECTED PART WAS RETURNED TO LIVANOVA DEUTSCHLAND FOR A DETAILED INVESTIGATION: IT WAS CONFIRMED AND REPRODUCED THAT THE BUBBLE SENSOR GAVE FALSE ALARMS, OVER-REACTING EVEN IF NO AIR BUBBLES WERE PRESENT. BASED ON THIS INFORMATION RECEIVED, THE EVENT HAS BEEN RE-ASSESSED AS NOT REPORTABLE. 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. UPON INSPECTION IT WAS ALSO FOUND THAT THE BUBBLE SENSOR CABLE WAS PARTIALLY DISCONNECTED AND THE CUSHIONS WERE NOT DEFLATED. NEW BUBBLE SENSOR WILL BE SENT TO CUSTOMER AS TROUBLESHOOTING. A DEVICE SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND IDENTIFIED THAT THE UNIT WAS MANUFACTURED IN 2018 AND NO OTHER SIMILAR EVENT HAS BEEN REPORTED. TAKING INTO ACCOUNT THE OUTCOME OF THE SERVICE ACTIVITY, IT CANNOT BE RULED OUT THAT THE MOST LIKELY ROOT CAUSE OF THE REPORTED ISSUE WAS RELATED TO THE PARTIAL DISCONNECTION OF THE CABLE.

Additional Manufacturer Narrative

A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE BUBBLE SENSOR. THE INCIDENT OCCURRED IN JAPAN. 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 THAT, DURING PRIMING, THE BUBBLE SENSOR WAS NOT CORRECTLY WORKING. IT WAS INSTALLED SEVERAL TIME EVEN ADDING GEL AND IT DID NOT IMPROVE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.