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

Catalog Number	6212001
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2026
Type of Reportable Event	Malfunction

• 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: 50167942
• Report Number: 1722028-2026-00113
• Device Sequence Number: 10040064
• Product Code: GKT
• UDI-Device Identifier: 05020583212008
• UDI-Public: 05020583212008
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2026

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: 2604102161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 08/18/2026; 09/10/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 08/31/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2026
• 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: 24 YR
• Patient Sex: Male