MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Mar 25, 2011 · Event occurred Mar 2, 2011
Report 1828100-2011-00730 · MDR key 2064610
Device
Generic name
Interface Module
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
7101Catalog number
7101
Product problems
- Device Displays Incorrect Message
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem
DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE SENSOR PROBE FAILED TO FUNCTION, AND AN ERROR MESSAGE WAS OBSERVED READING "INTERFACE MODULE COMM CHECK". THE DEVICE WAS NOT CHANGED OUT, AND THE PROCEDURE CONTINUED WITHOUT DELAY. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.