MalfunctionGKT

SPECTRA OPTIA®

Received Oct 17, 2022 · Event occurred Aug 10, 2022

Report 15619282 · MDR key 15619282

Device

Generic name

Separator, Automated, Blood Cell, Diagnostic

Manufacturer

Terumo Bct, Inc.

Model number

61000

Catalog number

378236

Product problems

Mechanical Problem
Device Sensing Problem

Patient

25915 DA · Male

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

Narrative

Description of Event or Problem

SPECTRA OPTIA INSTRUMENT (SN (B)(4) GAVE A CENTRIFUGE SPEED SENSOR MALFUNCTION ALARM DURING STEM CELL COLLECTION. CPL OPERATOR FOLLOWED INSTRUMENT RECOMMENDATIONS ON SCREEN. ALARM PERSISTED AND OPTIONS GIVEN WERE TO RINSE-BACK OR DISCONNECT. RINSE-BACK WAS COMPLETED. HOTLINE WAS NOTIFIED AND SERVICE WAS REQUESTED. INSTRUMENT TAKEN OUT OF SERVICE. ROUNDING ATTENDING, CC, AND PATIENTS ATTENDING NOTIFIED. MANUFACTURER RESPONSE FOR APHERESIS, SPECTA OPTIA (PER SITE REPORTER). VERIFIED CENTRIFUGE SPEED SENSOR MALFUNCTION.