MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Aug 22, 2011 · Event occurred Jul 26, 2011
Report 1828100-2011-02533 · MDR key 2255595
Device
Generic name
Interface Module
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
7101Catalog number
7101
Product problems
- Unable to Obtain Readings
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
DURING PREPARATION OF THE DEVICE FOR CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE HEMATOCRIT SATURATION CUVETTE READING WAS NOT CONNECTED. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED.
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.