MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Oct 13, 2011 · Event occurred Sep 13, 2011
Report 1828100-2011-03015 · MDR key 2315104
Device
Product problems
- Material Protrusion/Extrusion
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE SENSOR POPPED OUT OF THE CLIP EVERY FIVE MINUTES. THE DEVICE WAS NOT CHANGED OUT. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.