SORIN S3 BUBBLE DETECTOR SENSOR
Received Dec 6, 2016 · Event occurred Nov 10, 2016
Report 9611109-2016-00808 · MDR key 6149886
Device
Generic name
Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass
Manufacturer
Sorin Group DeutschlandModel number
23-07-40Product problems
- Device Displays Incorrect Message
- Device Displays Incorrect Message
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
PATIENT INFORMATION WAS NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE SORIN S3 BUBBLE DETECTOR SENSOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE CONFIRMED THE REPORTED ISSUE AND REPLACED THE BUBBLE SENSOR. SUBSEQUENT TESTING DID NOT IDENTIFY FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. 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 AN ERROR MESSAGE WAS DISPLAYED ON THE HEART-LUNCH MACHINE REGARDING THE SORIN S3 BUBBLE DETECTOR SENSOR DURING A PROCEDURE. THERE IS NO REPORT OF PATIENT INJURY.
Remedial action
- Other