MAUDE Adverse Event Report: TERUMO BCT RIKA; RIKA PLASMA SEPARATION SET

Catalog Number	6212001
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	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.Review shows that the donor fluid detector did not see air for the duration of the procedure, nor did the ac fluid detector.One draw and return cycle were completed, and the run was ended with saline rinseback.There were no air-related alarms for the duration of the procedure.Signals in the dlog do indicate that the line sensor sees air during the return cycle.The separation channel and soft cassette are designed to hold a certain amount of air.Signals in the dlog do not indicate that air passed through the donor fluid detector.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that they observed air bubbles in the line.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 h.6 and h.11.Investigation: the run data file (rdf) was analyzed for this event.Review shows that the donor fluid detector did not see air for the duration of the procedure, nor did the ac fluid detector.One draw and return cycle were completed, and the run was ended with saline rinseback.There were no air-related alarms for the duration of the procedure.Signals in the dlog do indicate that the line sensor sees air during the return cycle.The separation channel and soft cassette are designed to hold a certain amount of air.Signals in the dlog do not indicate that air passed through the donor fluid detector.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.It was confirmed that the air was not past the point of last detection for this event.No further reporting will be provided as this does not represent a reportable event.
Event or Problem Description
The customer reported that they observed air bubbles in the line.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: RIKA
• Common Device Name: RIKA PLASMA SEPARATION 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: 22782828
• Report Number: 1722028-2025-00178
• Device Sequence Number: 9906844
• Product Code: GKT
• UDI-Device Identifier: 05020583212008
• UDI-Public: 05020583212008
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: BK241097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: 6212001
• Device Lot Number: 2504252161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/04/2025
• Date Device Manufactured: 04/25/2025
• 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 Sex: Unknown