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

Model Number	42000
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	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported potential hemolysis.Donor information and outcome are unknown at this time.There was no serious injury or medical intervention that occurred for this event.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation: a service technician checked out the machine at the site.The sensor line was cleaned.An auto test and fluid test were successfully completed.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: a service technician checked out the machine at the site.The sensor line was cleaned.An auto test and fluid test were successfully completed.The device serial number history report indicates no further related issues have been reported for this device.A disposable complaint history search could not be performed, because the lot number was not provided by the customer during the complaint submission.A dhr could not be performed because the lot number was not provided by the customer after multiple attempts.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported potential hemolysis.Donor information and outcome are unknown at this time.There was no serious injury or medical intervention that occurred for this event.The collection set is not available for return because it was discarded by the customer.
Event or Problem Description
The customer reported potential hemolysis.There was no serious injury or medical intervention that occurred for this event.Donor information and further procedural details are not available because the customer failed to respond after multiple attempts.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, h.6 and h.11.Corrected information is provided in d.4.Investigation: a service technician checked out the machine at the site.The sensor line was cleaned.An auto test and fluid test were successfully completed.The device serial number history report indicates no further related issues have been reported for this device.A disposable complaint history search could not be performed, because the lot number was not provided by the customer during the complaint submission.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Root cause: a root cause assessment was performed for this complaint.Based on the available information, a definitive root cause for hemolysis could not be determined but it is likely due to one or a combination of the possible causes listed below: donor physiology such as icteric plasma or lipemic plasma.User loading errors that cause occlusions manufacturing errors that cause disposable occlusions.

• 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: 23647451
• Report Number: 1722028-2025-00258
• Device Sequence Number: 21345828
• 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: 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,Followup
• Report Date (Section B): 11/25/2025

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
• Device Catalogue Number: 6212001
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 01/13/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/12/2026; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2023
• 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 Sex: Unknown