MalfunctionDTY

TERUMO CDI 100 MONITOR

Received Feb 11, 2011 · Event occurred Jan 17, 2011

Report 1828100-2011-00177 · MDR key 1997783

Device

Generic name

Monitor

Manufacturer

Terumo Cardiovascular Systems Corp.

Model number

100

Catalog number

100

Product problems

Fracture

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 CLIP WAS BROKEN. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. THE DEVICE WAS USED FOR THE PROCEDURE. THE USER REPORTED THAT THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO A PT AS A RESULT OF THIS EVENT.