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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a service technician ran a fluid test with passing results.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported donor had post donations dae-hemoglobin in their urine.Patient information and outcome are unknown at this time.
Additional Manufacturer Narrative
This report is being filed to provide additional information in a.1, a.2, a.3, a.4, b.5, b.5, b.6, e.1, h.6 and h.11.Investigation: a service technician ran a fluid test with passing results.The run data file (rdf) was analyzed for this event.No alarms occurred during this run, target volume of 1023 ml was collected, and donor received 500 ml of saline.No device issue is suspected.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported donor had post donations dae-hemoglobin in their urine.Per the customer, the unit has already been proceeded and shipped.No concerns were reported by the laboratory.Per customer "donor did not report seeking further treatment, no further concerns reported by donor".Full donor id: (b)(6).
Event or Problem Description
The customer reported donor had post donations dae-hemoglobin in their urine.Per the customer, the unit was already been proceeded and shipped.No concerns were reported by the laboratory.Per customer "donor did not report seeking further treatment, no further concerns reported by donor".Full donor id: (b)(6).
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a service technician ran a fluid test with passing results.The run data file (rdf) was analyzed for this event.No alarms occurred during this run, target volume of 1023 ml was collected, and donor received 500 ml of saline.No device issue is suspected.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 there was no hemolysis and no medical intervention occurred for this event.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: 22003557
• Report Number: 1722028-2025-00116
• Device Sequence Number: 18489507
• Product Code: GKT
• UDI-Device Identifier: 05020583420007
• UDI-Public: 05020583420007
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: BK241097
• 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): 05/12/2025

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
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 05/15/2025; 07/09/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/05/2025; 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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 Age: 43 YR
• Patient Sex: Male