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

Model Number	42000
Medical Device Problem Codes	Fire (1245); Device Difficult to Maintain (3134); 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	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the device was being service by a service technician at the customer sire.The interface cca was replaced.Electrical safety testing was not performed prior to applying power to the device.When power was applied to the unit, visible sparks were observed, followed by a small flame (approximately ¼ inch in size) on the multifunction cca board.The side panels were removed at the time, and the fire was visually confirmed.The machine shut down immediately.It was then manually disconnected from power, and the flame was extinguished by blowing on it.The fire did not burn out on its own.At this time, the observed damage appears to be limited to the multifunction cca.The control computer does not appear to be damaged.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
During equipment required maintenance, upon inspection the technician reported seeing a flame on the multifunction cca while servicing the device.Technician/patient age, weight and outcome are unknown at this time.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, h.6 and h.11 and corrected information in d.8, e.1, e.3, a.1 and a.3a.Investigation: the device was being service by a service technician at the customer site.The interface cca was replaced.Electrical safety testing was not performed prior to applying power to the device.When power was applied to the unit, visible sparks were observed, followed by a small flame (approximately ¼ inch in size) on the multifunction cca board.The side panels were removed at the time, and the fire was visually confirmed.The machine shut down immediately.It was then manually disconnected from power, and the flame was extinguished by blowing on it.The fire did not burn out on its own.At this time, the observed damage appears to be limited to the multifunction cca.The control computer does not appear to be damaged.Multiple photographs were submitted in lieu of the disposables set to aid in the investigation.Analysis of the images revealed burnt components on the multifunction cca.The reported allegation was confirmed.One year of service history was reviewed for this device with no further issues related to the reported condition "thermal event" identified.A service technician completed testing of the device on multiple occasions and completed the multifunction and fluid tests, which were completed successfully.The device serial number history report indicates no further related issues have been reported for this device.The multifunction cca was returned to terumo bct and investigated.There were notable burn marks at the on the u8 component and the r25 component was broken off the board.The r25 was likely damaged while servicing the device when the interface cca was replaced for the original out of service reason.Correction a terumo bct representative contacted the customer regarding this incident.On april 29, 2026, system engineer reached out to the customer to remind them to be careful not to damage other components when servicing the device.The customer was also reminded to address any components that have been accidentally damaged.The customer responded and stated that they will communicate and remind all technicians of this information.Root cause: a root cause assessment was performed for the thermal event of this complaint.Based on the available evidence from the investigation, the assessment concluded that the most likely root cause was a technician error during servicing of the device, resulting in damage to a component on the multifunction cca.
Event or Problem Description
It was reported that during equipment required maintenance, upon inspection the technician reported seeing a flame on the multifunction cca while servicing the device.Technician/patient age and weight were not provided.It was reported that there was no serious injury or medical intervention.

• 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: verenia oliver ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 24640905
• Report Number: 1722028-2026-00041
• Device Sequence Number: 9895080
• Product Code: GKT
• UDI-Device Identifier: 05020583420007
• UDI-Public: 05020583420007
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK231035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/14/2026; 05/13/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 05/05/2026; 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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: Male