MalfunctionDTY
TERUMO CDI 100 BLOOD MONITOR
Received Jun 24, 2011 · Event occurred May 29, 2011
Report 1828100-2011-01763 · MDR key 2152753
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 "PROBE CALIBRATION ERROR DETECTED" MESSAGE OCCURRED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO A PT AS A RESULT OF THIS EVENT.