MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Jun 28, 2011 · Event occurred Jun 3, 2011
Report 1828100-2011-01808 · MDR key 2152398
Device
Generic name
Interface Module
Manufacturer
Terumo Cardiovascular System Corp.Model number
7101Catalog number
7101
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 FAILURE" 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.