SORIN S3 BUBBLE DETECTOR

Additional Manufacturer Narrative

THERE WAS NO PATIENT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE SORIN S5 SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN S3 BUBBLE DETECTOR ALARMED WHEN NO BUBBLE WAS PRESENT. THE SENSOR WAS EXCHANGED BUT IT DID NOT RESOLVE THE ISSUE. THIS ISSUE OCCURRED DURING PRIMING, SO THERE WAS NO PATIENT INVOLVEMENT. 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 WHEN NO BUBBLE WAS PRESENT. THE SENSOR WAS EXCHANGED BUT IT DID NOT RESOLVE THE ISSUE. THIS ISSUE OCCURRED DURING PRIMING, SO THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

SORIN GROUP (B)(4) MANUFACTURES THE SORIN S5 SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN S3 BUBBLE DETECTOR ALARMED WHEN NO BUBBLE WAS PRESENT. THE SENSOR WAS EXCHANGED BUT IT DID NOT RESOLVE THE ISSUE. THIS ISSUE OCCURRED DURING PRIMING, SO THERE WAS NO PATIENT INVOLVEMENT. A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE PERFORMED A VISUAL INSPECTION AND FUNCTIONAL TESTS AND WAS UNABLE TO CONFIRM THE REPORTED ISSUE. THE SERVICE REPRESENTATIVE PERFORMED A TECHNICAL SAFETY INSPECTION WITHOUT FAULT AND RETURNED THE UNIT TO THE CUSTOMER. AS A THE ISSUE WAS NOT REPRODUCED, A ROOT CAUSE COULD NOT BE DETERMINED AND NO CORRECTIVE ACTIONS WERE IDENTIFIED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. SORIN GROUP (B)(5) WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS TYPE OF ISSUE. EVALUATED BY SORIN GROUP SERVICE REP.