MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Jun 28, 2011 · Event occurred Jun 2, 2011
Report 1828100-2011-01810 · MDR key 2152384
Device
Product problems
- Device Displays Incorrect Message
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT A COLOR CHIP ERROR MESSAGE OCCURRED. THE DEVICE WAS NOT CHANGED OUT. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.