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	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
Event or Problem Description
Customer reported that the device alarmed (4403 potential rbc spillover detect and 4402 potential hemolysis detect) and the donation was ended.After letting the samples set for an hour, the hemolysis was identified in the test tube and collection line of the rika bottle.The plasma was an orange-red color in the bottle at the end of the donations and the tubing leading to the bottle was a dark red color.Anticoagulant and saline were connected to the collection setup and both solutions were correctly attached.Per customer "the donor was monitored for 15 minutes due to the cell loss (the rinseback could not be performed).The donor did not experience any adverse events from the potential hemolysis or cell loss.".
Additional Manufacturer Narrative
This report is being filed to provide additional information in g1, h6 and h11.Investigation: the device was inspected by an onsite tbct technician on 12/16/2025.The centrifuge and centrifuge motor were replaced by center technician on 12/31/2025 with passing functional checkout results.Device has been returned to service with no reported issues since.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A photograph was submitted in lieu of the product return to aid in the investigation.Upon review, the reported allegation was confirmed.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 device alarmed as intended for hemolysis and there was no concern for hemolysis return to donor.No further reporting will be provided as this does not represent a reportable event.
Event or Problem Description
The customer reported that the device alarmed (4403 potential rbc spillover detect and 4402 potential hemolysis detect) and the donation was ended.After letting the samples set for an hour, the hemolysis was identified in the test tube and collection line of the rika bottle.The plasma was an orange-red color in the bottle at the end of the donations and the tubing leading to the bottle was a dark red color.Anticoagulant and saline were connected to the collection setup and both solutions were correctly attached.Per customer "the donor was monitored for 15 minutes due to the cell loss (the rinseback could not be performed).The donor did not experience any adverse events from the potential hemolysis or cell loss." unit (b)(4).
Additional Manufacturer Narrative
This report is being filed to provide additional information in a.5, b.5, b.7, d.1, h.6 and h.11.Investigation: the device was inspected by an onsite tbct technician on 12/16/2025.The centrifuge and centrifuge motor were replaced by center technician on 12/31/2025 with passing functional checkout results.Device has been returned to service with no reported issues since.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A photograph was submitted in lieu of the product return to aid in the investigation.Upon review, the reported allegation was confirmed.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that the device alarmed (4403 potential rbc spillover detect and 4402 potential hemolysis detect) and the donation was ended.After letting the samples set for an hour, the hemolysis was identified in the test tube and collection line of the rika bottle.The plasma was an orange-red color in the bottle at the end of the donations and the tubing leading to the bottle was a dark red color.Anticoagulant and saline were connected to the collection setup and both solutions were correctly attached.Per customer "the donor was monitored for 15 minutes due to the cell loss (the rinseback could not be performed).The donor did not experience any adverse events from the potential hemolysis or cell loss." unit (b)(4).

• 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: verenia oliver ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 23945948
• Report Number: 1722028-2026-00003
• Device Sequence Number: 10724282
• Product Code: GKT
• UDI-Device Identifier: 05020583420007
• UDI-Public: 05020583420007
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/02/2026

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: 12/10/2025
• Supplement Date Received by Manufacturer: 02/14/2026; 04/01/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 03/10/2026; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2023
• 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: 27 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic