FLOW SENSOR 3/8"

Additional Manufacturer Narrative

A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE FLOW SENSOR 3/8". THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE: THE FLOW SENSOR WAS NOT MEASURING CORRECTLY. THE FLOW SENSOR READ LOWER VALUES THAN THE REAL ONES: IT SHOULD HAVE BEEN 1 LPM BUT IT APPEARED TO BE 0.72 LPM. 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 RECEIVED A REPORT THAT A FLOW SENSOR 3/8" USED WITH A CENTRIFUGAL PUMP DID NOT WORK DURING PROCEDURE. IT READ LOWER VALUES THAN THE REAL ONES. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

H10: THROUGH FOLLOW-UP COMMUNICATION WITH LIVANOVA FIELD SERVICE REPRESENTATIVE, IT WAS LEARNED THAT DURING DEVICE TESTING ZERO CALIBRATION WAS CHECKED AND WAS NOT THE ISSUE, SINCE THE SAME PROBLEM CONTINUED AFTERWARDS. 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.

Description of Event or Problem

SEE INITIAL REPORT.

Additional Manufacturer Narrative

H10: COMPLAINED SENSOR IS MANUFACTURED BY A LIVANOVA SUPPLIER. THEREFORE, THE SUPPLIER HAS BEEN FORMALLY INFORMED OF THE EVENT. BASED ON THE INFORMATION COLLECTED, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT IS AN EARLY FAILURE OF FLOW SENSOR.