MalfunctionDTY
TERUMO CDI 500 BLOOD PARAMETER MONITOR
Received Sep 4, 2013 · Event occurred Aug 13, 2013
Report 1828100-2013-00816 · MDR key 3382886
Device
Product problems
- Device Inoperable
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS DEVICE IS BEING PHASED OUT IN THE GLOBAL MARKET. SERVICE PARTS ARE NO LONGER AVAILABLE.
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 WORKING. THE CUSTOMER DOES NOT TRUST ANY OF THE VALUES. THE SAT READ WAS VERY INACCURATE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THER WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.