inforMED
MalfunctionDTY

TERUMO CDI 101 MONITOR

Received Oct 16, 2014 · Event occurred Sep 15, 2014

Report 1828100-2014-00878 · MDR key 4189366

Device

Generic name

Cdi 101 (7101) Interface Model

Model number

101

Catalog number

101

Product problems

  • Incorrect Or Inadequate Test Results

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A PROCEDURE, THERE WAS AN IMPORTANT DEVIATION OF BLOOD PARAMETERS: HEMOGLOBIN (HGB) AND HEMATOCRIT (HCT). THE DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFUL. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

Additional Manufacturer Narrative

THE REPORTED COMPLAINT IS NOT VERIFIABLE. THIS DEVICE IS NO LONGER MARKETED IN THE UNITED STATES. THIS EVENT OCCURRED IN (B)(4). THIS DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER. THE PRODUCT CAN NOT BE ANALYZED TO DETERMINE FAILURE MODE.