MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Aug 23, 2011 · Event occurred Jul 27, 2011
Report 1828100-2011-02560 · MDR key 2256382
Device
Generic name
Interface Moduel
Manufacturer
Terumo Cardiovascular System Corp.Model number
7101Catalog number
7101
Product problems
- Crack
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING PREPARATION OF THE DEVICE FOR CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE END WAS CRACKED. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.