MalfunctionGKT

SPECTRA OPTIA

Received Apr 11, 2023 · Event occurred Mar 27, 2023

Report 16712690 · MDR key 16712690

Device

Generic name

Separator, Automated, Blood Cell, Diagnostic

Manufacturer

Terumo Bct, Inc.

Model number

12220

Lot number

2302036141

Product problems

Leak/Splash

Patient

19345 DA · Male

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

SETTING UP THE PLASMAPHERESIS MACHINE, SALINE STARTED LEAKING FROM THE FILTER PORTION OF THE SALINE SPIKE. CONTINUOUS DRIP DOES NOT STOP DRIPPING FROM THE FILTER. THE PATIENT WAS NOT ON THE MACHINE, AND THIS WAS WHILE WE WERE PREPARING FOR THE PATIENT.