MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Feb 19, 2013 · Event occurred Jan 26, 2013
Report 1828100-2013-00139 · MDR key 2974403
Device
Product problems
- Device Emits Odor
- Failure to Power Up
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, WHEN THE UNIT WAS "SWITCHED ON", IT DID NOT POWER UP AND THE UNIT WAS EMITTING AN ODOR SIMILAR TO A SULPHUR SMELL. THE UNIT WAS SWITCHED OFF AND WAS NOT USED FOR THE PROCEDURE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE AS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.