MalfunctionGKT
SPECTRA OPTIA®
Received Nov 17, 2022 · Event occurred Oct 1, 2022
Report 15814678 · MDR key 15814678
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct, Inc.Model number
P102624Lot number
2208303230
Product problems
- Fluid/Blood Leak
Patient
14600 DA · Male
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
156 MINUTES INTO THE APHERESIS TREATMENT WITH FILTRATION PLASMAPHERESIS (FFP) MACHINE, IT ALARMED OF A BLOOD LEAK. A BLOOD LEAK WAS CONFIRMED AT THE INLET PORT OF THE CENTRIFUGE CHAMBER. TREATMENT WAS TERMINATED WITHOUT RINSE BACK OF BLOOD IN THE SYSTEM. ESTIMATED BLOOD LOSS WAS 225 ML. THE PATIENT'S HEMOGLOBIN AND HEMATOCRIT WERE STABLE AND VITAL SIGNS WERE STABLE AT DISCHARGE. TERUMO WAS NOTIFIED OF THE KIT ISSUE AND LOT NUMBER.