InjuryLKN
TERUMO SPECTRA OPTIA APHERESIS SYSTEM TUBING
Received Mar 30, 2022 · Event occurred Mar 24, 2022
Report MW5108655 · MDR key 13966607
Device
Generic name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Manufacturer
Terumo Bct, Inc.Lot number
2203033130
Product problems
- Fluid/Blood Leak
Patient
66 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
BLOOD LEAK IN PLASMAPHERESIS TUBING DURING PROCEDURE. THIS IS THE 3RD TIME THIS RECENTLY HAPPENED USING THIS TYPE OF TUBING DURING THIS PROCEDURE. FDA SAFETY REPORT ID # (B)(4).