MalfunctionGKT
SPECTRA OPTIA®
Received Nov 21, 2022 · Event occurred Oct 25, 2022
Report 15833364 · MDR key 15833364
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct, Inc.Model number
12220Lot number
2204216141
Product problems
- Fluid/Blood Leak
- Contamination /Decontamination Problem
Patient
17520 DA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AT THE COMPLETION OF THE APHERESIS TREATMENT, THE NURSE OPENED THE CENTRIFUGE CHAMBER TO FIND BLOOD SPRAY INSIDE THE CHAMBER. FLUID LEAK DETECTOR ALARM DID NOT SOUND DURING PROCEDURE. UNABLE TO FIND DEFECT THROUGH VISUAL EXAMINATION ON KIT ALTHOUGH PHOTOS OF INCIDENT SUGGEST THAT THE LEAK HAPPENED AT THE CONNECTOR SITE ON THE CHANNEL.