MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Sep 14, 2012 · Event occurred Aug 17, 2012
Report 1828100-2012-01167 · MDR key 2750526
Device
Product problems
- Failure to Back-Up
- False Reading From Device Non-Compliance
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE UNIT WOULD NOT HOLD VALUES AND WAS DRIFTING. THE DEVICE WAS NOT CHANGED OUT, AS THE USER KEPT RUNNING SAMPLES AND MAKING ADJUSTMENTS. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PT.