MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Sep 16, 2011 · Event occurred Aug 19, 2011
Report 1828100-2011-02791 · MDR key 2271402
Device
Product problems
- Break
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 THE PROBE HAD A BROKEN CLIP. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
DEVICE NOT RETURNED.