SORIN S3 BUBBLE DETECTOR

Additional Manufacturer Narrative

LIVANOVA (B)(4) MANUFACTURES THE S3 BUBBLE DETECTOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). THE BUBBLE SENSOR AND MODULE WERE RETURNED TO LIVANOVA (B)(4) FOR INVESTIGATION. DURING EVALUATION, THE REPORTED ISSUE WAS CONFIRMED. THE VGA GAIN VALUE OF THE BUBBLE SENSOR WAS FOUND TO BE OUTSIDE OF THE ACCEPTANCE RANGE, RESULTING IN THE BUBBLE SENSOR NOT BEING RELIABLE IN ITS READING (I.E FALSELY ALARMING). THIS IS A KNOWN ISSUE AND A ROOT CAUSE INVESTIGATION HAS ALREADY BEEN CLOSED, CONCLUDING THAT THE RISK OF AN UNINTENDED CHANGE IS VERY LOW. AS CORRECTIVE ACTION, LIVANOVA (B)(4) IS PLANNING TO DEVELOP AN ENTIRELY NEW SENSOR.

Additional Manufacturer Narrative

PATIENT INFORMATION WAS NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE SORIN S3 BUBBLE DETECTOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

Description of Event or Problem

SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN S3 BUBBLE DETECTOR ALARMED RANDOMLY AND THE TUBING SIZE SETTING CHANGED ON ITS OWN DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

Additional Manufacturer Narrative

LIVANOVA (B)(4) MANUFACTURES THE S3 BUBBLE DETECTOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). ON JANUARY 24, 2017, A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS UNABLE TO REPRODUCE THE REPORTED FAULT. THE BUBBLE SENSOR AND BUBBLE MODULE WERE REPLACED AS A PRECAUTION. THE DEVICE WAS FUNCTIONALLY TESTED WITHOUT ISSUE AND WAS RETURNED TO SERVICE. THESE SERVICE RESULTS WERE INADVERTENTLY NOT INCLUDED IN THE INITIAL REPORT, SUBMITTED FEBRUARY 13, 2017. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. EVALUATED ON SITE BY SERVICE REP.