MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Nov 15, 2013 · Event occurred Oct 22, 2013
Report 1828100-2013-01010 · MDR key 3658007
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
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE HEMATOCRIT READINGS WERE NOT STABLE. 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 PATIENT.