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	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.The review found that the device detected air at the donor line fluid detector very briefly during the first draw cycle, and then did not detect air at the donor line fluid detector again for the remainder of the run.The ac line fluid detector also did not detect air at any point during the run.During the 5th return cycle, the device detected fluid at the leak detector, indicating that there was a centrifuge leak.The run was then immediately ended.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that they observed air in the donor line.Donor 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.The review found that the device detected air at the donor line fluid detector very briefly during the first draw cycle, and then did not detect air at the donor line fluid detector again for the remainder of the run.The ac line fluid detector also did not detect air at any point during the run.During the 5th return cycle, the device detected fluid at the leak detector, indicating that there was a centrifuge leak.The run was then immediately ended.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 no air was infused to the donor during this event, no medical intervention was performed, and the donor is currently in good standing at the center.The air was noticed in the donor line tubing at teardown; no photos were taken.The system engineer reviewed the dlog for this run and have found that the device detected air at the donor line fluid detector very briefly during the first draw cycle and then did not detect air at the donor line fluid detector again for the remainder of the run.During the 5th return cycle, the device detected fluid at the leak detector, indicating that there was a centrifuge leak.The run was then immediately ended.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 in the donor line.Donor 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: 23543317
• Report Number: 1722028-2025-00246
• Device Sequence Number: 21253493
• Product Code: GKT
• UDI-Device Identifier: 05020583212008
• UDI-Public: 05020583212008
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 11/13/2025

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: 2506243261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2025
• 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