InjuryGKT
TERUMO SPECTRA OPTIA APHERESIS SYSTEM TUBING
Received Mar 31, 2022 · Event occurred Mar 25, 2022
Report MW5108685 · MDR key 13976602
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct, Inc.Lot number
2203033130
Product problems
- Fluid/Blood Leak
Patient
73 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
BLOOD LEAK AT BEGINNING OF PLASMAPHERESIS TREATMENT. THIS IS THE 3RD OCCURRENCE WITH THE SAME LOT NUMBER OF TUBING. THE LEAK WAS AT THE SAME LOCATION IN ALL 3 TUBING SETS. FDA SAFETY REPORT ID# (B)(4).