MalfunctionDTY
TERUMO CDI 100 MONITOR
Received May 20, 2011 · Event occurred Apr 26, 2011
Report 1828100-2011-01405 · MDR key 2102462
Device
Product problems
- Device Operates Differently Than Expected
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 BRACKET WAS FLIMSY AND WOULD NOT HOLD ONTO POLE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.