MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Jun 14, 2011 · Event occurred May 20, 2011
Report 1828100-2011-01673 · MDR key 2176017
Device
Product problems
- Calibration Problem
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 A MESSAGE REQUIRING RECALIBRATION OCCURRED AFTER 1 HR OF USAGE. 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.