MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Apr 4, 2012 · Event occurred Mar 12, 2012
Report 1828100-2012-00285 · MDR key 2519754
Device
Product problems
- False Reading From Device Non-Compliance
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE BLOOD PARAMETER MONITOR READINGS WERE INACCURATE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT. INVESTIGATION IN PROCESS, BUT NOT YET COMPLETED.