TERUMO CDI 101 MONITOR
Received Oct 20, 2014 · Event occurred Sep 9, 2014
Report 1828100-2014-00870 · MDR key 4196947
Device
Generic name
Cdi 101 (7101) Interface Model
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
101Catalog number
101
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A PROCEDURE, THERE WERE DRIFTING HEMATOCRIT (HCT) VALUES. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.
Additional Manufacturer Narrative
THE REPORTED COMPLAINT WAS NOT VERIFIABLE. THIS DEVICE IS NO LONGER MARKETED IN THE UNITED STATES. THIS EVENT OCCURRED IN (B)(6). THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION AND CAN NOT BE ANALYZED TO DETERMINE THE FAILURE MODE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.