SPECTRA OPTIA®
Received Sep 4, 2025 · Event occurred Jul 8, 2025
Report 22962993 · MDR key 22962993
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct, Inc.Model number
12220Catalog number
12220
Lot number
2502183141
Product problems
- Crack
- Leak/Splash
- Device Contamination with Body Fluid
- Therapeutic or Diagnostic Output Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WE HAD THREE SPECTRA OPTIA APHERESIS SYSTEM SET UPS MALFUNCTION AND NEEDED REPLACED. I CONTACTED SPECTRA ON [DATE REDACTED] THE TUBING CRACKED INSIDE CENTRIFUGE AND SPRAYED BLOOD INSIDE MACHINE. SPECTRA STATED A TECH WOULD COME OUT TO CLEAN MACHINE AND THEY WOULD COMPENSATE OUR FACILITY FOR THE FAULTY EQUIPMENT. SINCE THEN, WE HAD ANOTHER SET UP FAIL LOT NUMBER 2503103341 RED 12220 EXPIRE 2027-03-01 AND A THIRD SET UP LOT NUMBER 2502183141 REF 12220 EXPIRES 2027-02-01. THESE LAST TWO FAILURES WERE CAUGHT DURING SET UP.