MAUDE Adverse Event Report: TERUMO BCT, INC. SPECTRA OPTIA®; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Model Number	12220
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: SPECTRA OPTIA®
• Common Device Name: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT, INC.; 10811 west collins ave.; lakewood CO 80215
• MDR Report Key: 22962993
• Report Number: 22962993
• Device Sequence Number: 9636017
• Product Code: GKT
• UDI-Device Identifier: 05020583122208
• UDI-Public: (01)05020583122208
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/15/2025
• Report Date (Section F): 07/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 12220
• Device Catalogue Number: 12220
• Device Lot Number: 2502183141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/15/2025