MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Sep 14, 2011 · Event occurred Aug 22, 2011
Report 1828100-2011-02798 · MDR key 2259483
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 CLIP WAS BROKEN. 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.
Additional Manufacturer Narrative
DEVICE NOT RETURNED. BREAK.