MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Feb 4, 2011 · Event occurred Jan 10, 2011
Report 1828100-2011-00131 · MDR key 1992897
Device
Generic name
Interface Module
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
7101Catalog number
7101
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED, THE DARK GREY/BEIGE PART TIP WAS BROKEN WHERE IT LOCKS INTO THE CUVETTE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED, THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO ADVERSE CONSEQUENCES TO A PATIENT AS A RESULT OF THIS EVENT.