S5 BUBBLE DETECTOR SENSOR 3/16''

Additional Manufacturer Narrative

THERE WAS NO PATIENT INVOLVEMENT. THE S5 BUBBLE DETECTOR SENSOR 3/16'' IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO S5 BUBBLE DETECTOR SENSOR 3/8'', WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K955152). LIVANOVA (B)(4) MANUFACTURES THE S5 BUBBLE DETECTOR SENSOR 3/16''. THE INCIDENT OCCURRED IN (B)(6). LIVANOVA INITIATED AN INVESTIGATION. 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 (B)(4) RECEIVED A REPORT THAT A BUBBLE SENSOR 3/16'' WAS FOUND TO BE DEFECTIVE DURING PRIMING. NO ADDITIONAL DETAILS WERE PROVIDED.THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

H.10: THROUGH FOLLOW UP COMMUNICATION WITH THE SERVICE ENGINEER, IT WAS LEARNED THAT THE BUBBLE SENSOR MAY HAVE HAD A BROKEN CABLE. HOWEVER, THIS COULD NOT BE CONFIRMED AND THIS CASE IS CONSERVATIVELY CONSIDERED AS REPORTABLE EVENT. NO TREND OR PATTERN HAS BEEN IDENTIFIED FOR BUBBLE SENSOR MALFUNCTION. NO OTHER INFORMATION HAS BEEN MADE AVAILABLE ON THIS SPECIFIC CASE AND THE EXACT MALFUNCTION OF THE BUBBLE SENSOR COULD NOT BE DETERMINED.

Description of Event or Problem

SEE INITIAL REPORT.

Additional Manufacturer Narrative

H.10: NO OTHER INFORMATION HAS BEEN MADE AVAILABLE ON THIS SPECIFIC CASE AND THE MALFUNCTION OF THE BUBBLE SENSOR COULD NOT BE DETERMINED. A QUOTATION TO CUSTOMER FOR A NEW BUBBLE SENSOR HAS BEEN ISSUED AND IS STILL PENDING APPROVAL. THE DEFECTIVE BUBBLE SENSOR WAS MANUFACTURED IN 2016 AND NO OTHER COMPLAINTS WERE SUBMITTED IN THE PAST. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

SEE INITIAL REPORT.