MalfunctionGKT
SPECTRA OPTIA®
Received Jul 2, 2024 · Event occurred Apr 1, 2024
Report 19654349 · MDR key 19654349
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct, Inc.Model number
OPTIAPatient
77 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
HALF WAY THROUGH THE TREATMENT, THE MACHINE ALARMED WITH A BLOOD LEAK. PROCEDURE WAS STOPPED AND SPLATTERING WAS FOUND INSIDE.