SORIN S5 BUBBLE DETECTOR

Additional Manufacturer Narrative

LIVANOVA (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). THE BUBBLE SENSOR WAS RETURNED TO LIVANOVA (B)(4) FOR EVALUATION. DETAILED INSPECTION IDENTIFIED A TEAR IN THE RIGHT SIDE PILLOW AND THE GEL HAD LEAKED OUT. THE SPECIFIC CAUSE OF THE TEAR CANNOT BE DETERMINED AS IT OCCURRED DURING USE BY THE CUSTOMER. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. A TREND OF FAILING BUBBLE SENSORS DUE TO LEAKS IN CUSHIONS HAS NOT BEEN IDENTIFIED SO FAR. HOWEVER, CAPA (B)(4) WAS INITIATED TO EVALUATE THE LIFETIME OF THE BUBBLE SENSOR.

Additional Manufacturer Narrative

SORIN GROUP (B)(4) MANUFACTURES THE SORIN CENTRIFUGAL PUMP SYSTEM. THE INCIDENT OCCURRED IN (B)(4). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN S5 BUBBLE DETECTOR CUSHIONS WERE FOUND TO BE DEFLATED DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS UNABLE TO IDENTIFY THE ISSUE ON SITE. THE BUBBLE SENSOR WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER INVESTIGATION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE. EVALUATION IN PROGRESS.

Description of Event or Problem

SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN S5 BUBBLE DETECTOR CUSHIONS WERE FOUND TO BE DEFLATED DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.