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

Catalog Number	6212001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported a hemolyzed unit and no alarm occurred from a plasma donation.The hemolysis was identified after patient disconnect and was only observed in the bottle.Per the customer the anti-coagulant and saline solutions were attached correctly.The customer did not report any impact to the patient.Full patient identifier: (b)(6).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: kristi edgington ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 25695377
• Report Number: 1722028-2026-00088
• Device Sequence Number: 15883061
• Product Code: GKT
• UDI-Device Identifier: 05020583212008
• UDI-Public: 05020583212008
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK241097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/02/2026

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 Catalogue Number: 6212001
• Device Lot Number: 2602232161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: Not provided; 08/25/2026; 09/15/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 08/20/2026; 09/14/2026; 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2026
• 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: 37 YR
• Patient Sex: Male