MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Oct 2, 2013 · Event occurred May 1, 2013
Report 1828100-2013-00878 · MDR key 3435310
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE USER FACILITY'S PERFUSIONIST STATED THIS ISSUE HAS BEEN ONGOING SINCE MAY 2013.
Description of Event or Problem
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE BLOOD PARAMETER MONITOR (BPM) WAS NOT ACCURATE. THE DEVICE WAS NOT CHANGED OUT AND THEY WERE UNABLE TO USE FOR CASE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.