S5 SENSOR MODULE FOR BUBBLE DETECTOR

Additional Manufacturer Narrative

SERIAL NUMBER: (B)(4). DEVICE MANUFACTURER DATE (MM/DD/YYYY): 01/29/2015. (B)(4): NO CONSEQUENCE OR IMPACT TO PATIENT.

Additional Manufacturer Narrative

PATIENT INFORMATION WAS NOT PROVIDED. THE SERIAL NUMBER HAS NOT BEEN PROVIDED BY THE FACILITY. DEVICE HAS NOT BEEN RETURNED TO SORIN GROUP (B)(6). THE SERIAL NUMBER HAS NOT BEEN PROVIDED, SO THE MANUFACTURING DATE IS UNKNOWN. SORIN GROUP DEUTSCHLAND MANUFACTURES THE LEVEL SENSOR OF S5 SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP(B)(6) . SORIN GROUP (B)(6) RECEIVED A REPORT THE S5 SENSOR MODULE FOR BUBBLE DETECTOR OF SORIN S5 SYSTEM WAS NOT RECOGNIZED AND THE ALARM SOUNDED. PATIENT STATUS HAS NOT BEEN OBTAINED FROM THE FACILITY. THE INVESTIGATION IS ONGOING. A FOLLOW-UP WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

Description of Event or Problem

SORIN GROUP (B)(6) RECEIVED A REPORT THE S5 SENSOR MODULE FOR BUBBLE DETECTOR OF SORIN S5 SYSTEM WAS NOT RECOGNIZED AND THE ALARM SOUNDED. PATIENT STATUS HAS NOT BEEN OBTAINED FROM THE FACILITY.

Additional Manufacturer Narrative

SORIN GROUP (B)(4) MANUFACTURES THE LEVEL SENSOR OF S5 SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE DEVICE WAS RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. THE DEVICE WAS FUNCTIONALLY TESTED BY THE TECHNICIAN. HOWEVER, THE REPORTED ERROR COULD NOT BE REPRODUCED AND THE UNIT WORKED AS EXPECTED. A REPLACEMENT HAS BEEN PROVIDED TO THE CUSTOMER AS A PRECAUTION. NO FURTHER ISSUES HAVE BEEN REPORTED. AS THE REPORTED ISSUE COULD NOT BE REPRODUCED, A ROOT CAUSE COULD NOT BE DETERMINED AND CORRECTIVE ACTIONS WERE NOT IDENTIFIED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS TYPE OF ISSUE. EVALUATED BY SORIN GROUP (B)(4).