MAUDE Adverse Event Report: TERUMO BCT RIKA; RIKA PLASMA DONATION SYSTEM

Model Number	42000
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they observed possible (red blood cell) rbc spillover.Rbcs reached the plasma line without any alarms occurring.When the customer inspected the plasma line it was noted that the rbcs and plasma in the plasma line looked congealed.There were no issues noted in setup during setup investigation and the solutions were spiked correctly.Full patient identifier: (b)(6) per customer "donor was okay at the time of release and has donated since" the collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation: reviewing the run data file (rdf) showed there were signs of an rbc spillover and a potential for lipemia.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: reviewing the run data file (rdf) showed there were signs of an rbc spillover and a potential for lipemia.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.After additional investigation and review of internal reportability documents it was determined that the lipemia does not have the potential for injury to occur to the donor.No further reporting will be provided as this does not represent a reportable event.
Event or Problem Description
The customer reported that they observed possible (red blood cell) rbc spillover.Rbcs reached the plasma line without any alarms occurring.When the customer inspected the plasma line it was noted that the rbcs and plasma in the plasma line looked congealed.There were no issues noted in setup during setup investigation and the solutions were spiked correctly.Full patient identifier: (b)(6) per customer "donor was okay at the time of release and has donated since" the collection set is not available for return because it was discarded by the customer.

• Brand Name: RIKA
• Common Device Name: RIKA PLASMA DONATION SYSTEM
• 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: 23038529
• Report Number: 1722028-2025-00214
• Device Sequence Number: 21316398
• Product Code: GKT
• UDI-Device Identifier: 05020583420007
• UDI-Public: 05020583420007
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: BK210635
• 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): 09/12/2025

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 Model Number: 42000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male