MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

Catalog Number	12220
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged medical intervention but did not provide additional details.The following details of the procedure were provided, at the beginning of the priming of the tubing (with the blood), the following alarm was triggered: the cell concentration in the plasma tubing was higher than expected alarm.The doctor increased the target hematocrit, but it didn't work.The machine was changed using the same data: the exchange was completed without incident.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Lot number, manufacture date and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer alleged medical intervention but did not provide additional details.The following details of the procedure were provided, at the beginning of the priming of the tubing (with the blood), the following alarm was triggered: the cell concentration in the plasma tubing was higher than expected alarm.The doctor increased the target hematocrit, but it didn't work.The machine was changed using the same data: the exchange was completed without incident.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in a.2, a.3a, a.4, b.7, d.4, h.6 and h.11.Investigation: per follow up from the customer, the nurse on site ordered an increase of the patients target hematocrit.This did not include any unplanned medications.Investigation is in process, a follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: per follow up from the customer, the nurse on site ordered an increase of the patients target hematocrit.This did not include any unplanned medications.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.There was no medical intervention for this event, only standard run adjustments.No further reporting will be provided as this does not represent a reportable event.
Event or Problem Description
The customer alleged medical intervention but did not provide additional details.The following details of the procedure were provided, at the beginning of the priming of the tubing (with the blood), the following alarm was triggered: the cell concentration in the plasma tubing was higher than expected alarm.The doctor increased the target hematocrit, but it didn't work.The machine was changed using the same data: the exchange was completed without incident.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 22914020
• Report Number: 1722028-2025-00201
• Device Sequence Number: 21137550
• Product Code: GKT
• UDI-Device Identifier: 05020583122208
• UDI-Public: 05020583122208
• Combination Product (Y/N): N
• Initial Reporter Country: FG
• PMA/510(K) Number: K183081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2025

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 Catalogue Number: 12220
• Device Lot Number: 2411183141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 10/08/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/22/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 74 KG