MalfunctionGKT

SPECTRA OPTIA COLLECTION SET

Received Nov 20, 2018 · Event occurred Nov 7, 2018

Report 8089189 · MDR key 8089189

Device

Generic name

Separator, Automated, Blood Cell, Diagnostic

Manufacturer

Terumo Bct, Inc.

Model number

2877

Product problems

Material Twisted/Bent

Patient

16790 DA

No Known Impact Or Consequence To Patient
No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

SHORTLY AFTER PROCEDURE HAD STARTED, THE MACHINE ALARMED THAT THE CENTRIFUGE TUBING WAS TWISTED AND MACHINE PROMPT ME TO DISCONNECT PATIENT. UNABLE TO RETURN BLOOD IN TUBING. DRS. AND PTS COORDINATOR NOTIFIED.