MalfunctionDTY
TERUMO CDI 101 MONITOR
Received May 25, 2011 · Event occurred May 2, 2011
Report 1828100-2011-01485 · MDR key 2107760
Device
Generic name
Interface Module
Manufacturer
Terumo Cardiovascular System CorpModel number
7101Catalog number
7101
Product problems
- Material Separation
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 CLAMP 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.