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 Codes	Hemolysis (1886); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a service technician checked out the machine at the customer site.A successful multifunction cca autotest and fluid test were performed.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported potential hemolysis.Patient information is unknown at this time.No injury or medical intervention were required for this event.
Event or Problem Description
The customer reported potential hemolysis.Patient information is unknown at this time.No injury or medical intervention were required for this event.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a service technician checked out the machine at the customer site.A successful multifunction cca autotest and fluid test were performed.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 log file and found there was an rbc spillover alarm that occurred during the second draw cycle, after which the procedure was ended.There was no indication of hemolysis from the line sensor signals, and no fluid was returned to the donor following the spillover alarm.No further reporting will be provided as this does not represent a reportable event.

• 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: 24505948
• Report Number: 1722028-2026-00039
• Device Sequence Number: 15942627
• Product Code: GKT
• UDI-Device Identifier: 05020583420007
• UDI-Public: 05020583420007
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2024
• 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 Sex: Unknown