MalfunctionGKT

SPECTRA OPTIA®

Received Feb 14, 2024 · Event occurred Nov 20, 2023

Report 18703554 · MDR key 18703554

Device

Generic name

Separator, Automated, Blood Cell, Diagnostic

Manufacturer

Terumo Bct, Inc.

Lot number

2307216141

Patient

55 YR · Unknown

Hemorrhage/Blood Loss/Bleeding
Hemorrhage/Blood Loss/Bleeding

Narrative

Description of Event or Problem

TREATMENT INITIATED WITH GOAL FOR 1.0 EXCHANGE AND WHEN PATIENT WAS AT .7 EXCHANGE , CENTRIFUGE STOPPED AND BLOOD LEAK ALARM ACTIVATED. CENTRIFUGE COVER OPENED AND BLOOD NOTED IN CAVITY OF MACHINE. TREATMENT ENDED UNABLE TO RETURN BLOOD. NOTED TEAR IN THE CENTRIFUGE CHANNEL. APPROXIMATE BLOOD LOSS APPROXIMATED 240 ML. PATIENT ASYMPTOMATIC. PATIENT DISCHARGED TO AMBULATORY UNIT WITH STEADY GAIT.