BUBBLE SENSOR DETECTOR

Description of Event or Problem

LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A BUBBLE SENSOR DETECTOR WAS DEFECTIVE. NO ADDITIONAL INFORMATION IS AVAILABLE. IT CANNOT BE EXCLUDED THAT BUBBLE SENSOR DID NOT DETECT AIR BUBBLE. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THERE WAS NO PATIENT INVOLVEMENT. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. LIVANOVA DEUTSCHLAND MANUFACTURES THE BUBBLE SENSOR DETECTOR. THE INCIDENT OCCURRED IN TRENTO, ITALY. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative

H10: THROUGH FOLLOW-UP COMMUNICATION WITH LIVANOVA FIELD SERVICE REPRESENTATIVE, IT WAS CLARIFIED THAT THE SENSOR WAS NOT RECOGNIZED BY THE S5 UNIT. THEREFORE, THE ISSUE IS ALWAYS DETECTABLE AS SOON AS THE SENSOR IS PLUGGED IN. THUS, THERE IS UNLIKELY POSSIBILITY TO CAUSE DEATH OR SERIOUS INJURY. THE EVENT HAS BEEN REASSESSED AS NOT REPORTABLE. LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE: BUBBLE SENSOR WAS NOT RECOGNIZED BY THE S5 CONSOLE. IN ORDER TO FIX THE ISSUE, BOTH BUBBLE SENSOR AND BUBBLE MODULE WERE REPLACED. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. COMPLAINTS DATABASE ANALYSIS REVEALED THAT NO SIMILAR EVENT ON THIS DEVICE OCCURRED SINCE ITS INSTALLATION IN 2012. ROOT CAUSE OF THE REPORTED ISSUE COULD BE TRACED BACK TO FAULTY BUBBLE SENSOR AND MODULE MOST LIKELY DUE TO WEARING OF THE PARTS.

Description of Event or Problem

SEE INITIAL REPORT.