SORIN S3 BUBBLE DETECTOR

Additional Manufacturer Narrative

THE INITIAL MEDWATCH REPORT FOR THIS EVENT, FILED ON JUNE 3, 2016, REFERENCED AN S3 BUBBLE DETECTOR, WHEN THE INVOLVED DEVICE WAS AN S5 BUBBLE DETECTOR. SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN S5 BUBBLE DETECTOR INTERMITTENTLY GAVE A FALSE ALARM DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. BRAND NAME: SORIN S5 BUBBLE DETECTOR. PMA/510K#: K071318. SORIN GROUP (B)(4) MANUFACTURES THE SORIN S5 BUBBLE DETECTOR. 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 S5 BUBBLE DETECTOR INTERMITTENTLY GAVE A FALSE ALARM DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE PERFUSIONIST INFORMED THE SERVICE REPRESENTATIVE THAT THE BUBBLE SENSOR WAS REPLACED WITH A SPARE, WHICH RECTIFIED THE ISSUE. VISUAL INSPECTION OF THE REPLACED SENSOR IDENTIFIED DEFLATED BLADDERS. A NEW BUBBLE SENSOR WAS PROVIDED TO THE CUSTOMER TO REPLACE THE SPARE. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

Additional Manufacturer Narrative

THERE WAS NO REPORT OF PATIENT INJURY. THE DEVICE HAS NOT BEEN RETURNED TO SORIN GROUP (B)(4). SORIN GROUP (B)(4) MANUFACTURES THE SORIN S3 BUBBLE DETECTOR. 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 INTERMITTENTLY GAVE A FALSE ALARM DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE PERFUSIONIST INFORMED THE SERVICE REPRESENTATIVE THAT THE BUBBLE SENSOR WAS REPLACED WITH A SPARE, WHICH RECTIFIED THE ISSUE. VISUAL INSPECTION OF THE REPLACED SENSOR IDENTIFIED DEFLATED BLADDERS. A NEW BUBBLE SENSOR WAS PROVIDED TO THE CUSTOMER TO REPLACE THE SPARE. 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 INTERMITTENTLY GAVE A FALSE ALARM DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

Additional Manufacturer Narrative

SORIN GROUP (B)(4) MANUFACTURES THE SORIN S3 BUBBLE DETECTOR. 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 INTERMITTENTLY GAVE A FALSE ALARM DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. THE REPORTED ISSUE WAS CAUSED BY A DAMAGED BUBBLE DETECTOR AND COULD BE RESOLVED BY REPLACING THE FAULTY COMPONENT. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. SORIN GROUP (B)(4) HAS INITIATED A ROOT CAUSE INVESTIGATION (B)(4) FOR THIS TYPE OF ISSUE. EVALUATED ON SITE BY SORIN SERVICE REP.