MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Oct 10, 2012 · Event occurred Sep 13, 2012
Report 1828100-2012-01303 · MDR key 2787490
Device
Product problems
- Leak/Splash
- Battery Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE MONITOR'S BATTERY WAS FOUND TO BE LEAKING AND BATTERY FAILURE OCCURRED. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED AND THE SUSPECT UNIT WAS TAKEN OUT OF SERVICE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT. THERE WAS NO REPORTED ADVERSE EVENT TO THE END USER AS WELL.
Additional Manufacturer Narrative
THE UNIT WAS TAKEN OUT OF SERVICE.