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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the machine was checked out at the customer site.The technician performed an ac pump cca, draw pump cca, return pump cca, soft cassette housing cca, multifunction cca and an auto test.All passed successfully.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that the machine allowed air bubbles to flow back toward the donor as well as allowed red cells to reach the bottle.Patient information and outcome are unknown at this time.
Event or Problem Description
The customer reported that the machine allowed air bubbles to flow back toward the donor as well as allowed red cells to reach the bottle.Patient information and outcome are unknown at this time.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: the machine was checked out at the customer site.The technician performed an ac pump cca, draw pump cca, return pump cca, soft cassette housing cca, multifunction cca and an auto test.All passed successfully.The customer did not respond to multiple attempts to obtain information for the investigation such as patient (recipient) information, recipient outcome, procedural details and lot information.Investigation is in process, a follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, h.6 and h.11.Investigation: the machine was checked out at the customer site.The technician performed an ac pump cca, draw pump cca, return pump cca, soft cassette housing cca, multifunction cca and an auto test.All passed successfully.The customer did not respond to multiple attempts to obtain information for the investigation such as patient (recipient) information, recipient outcome, procedural details and lot information.The device serial number history report indicates no further related issues have been reported for this device.The lot number was not provided after three follow up attempts, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.A dlog investigation could not be conducted for this incident as the collection id was not provided after three follow up attempts.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that the machine allowed air bubbles to flow back toward the donor as well as allowed red cells to reach the bottle.The customer did not respond to multiple attempts to obtain information for the investigation such as patient (recipient) information, recipient outcome, procedural details and lot information.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: the machine was checked out at the customer site.The technician performed an ac pump cca, draw pump cca, return pump cca, soft cassette housing cca, multifunction cca and an auto test.All passed successfully.The customer did not respond to multiple attempts to obtain information for the investigation such as patient (recipient) information, recipient outcome, procedural details and lot information.The device serial number history report indicates no further related issues have been reported for this device.The lot number was not provided after follow up attempts, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.A dlog investigation could not be conducted for this incident as the collection id was not provided after three follow up attempts.One year of service history was reviewed for this device with no further issues related to the reported condition identified investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that the machine allowed air bubbles to flow back toward the donor as well as allowed red cells to reach the bottle.The customer did not respond to multiple attempts to obtain information for the investigation such as patient (recipient) information, recipient outcome, procedural details and lot information.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: the machine was checked out at the customer site.The technician performed an ac pump cca, draw pump cca, return pump cca, soft cassette housing cca, multifunction cca and an auto test.All passed successfully.The customer did not respond to multiple attempts to obtain information for the investigation such as patient (recipient) information, recipient outcome, procedural details and lot information.The device serial number history report indicates no further related issues have been reported for this device.The lot number was not provided after follow up attempts, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.A dlog investigation could not be conducted for this incident as the collection id was not provided after three follow up attempts.One year of service history was reviewed for this device with no further issues related to the reported condition identified root cause: a root cause assessment was performed for potential air to donor of this complaint.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: *loading issue failure to lay the plasma bottle flat in the bottle holder improperly spiked ac or failure to remove air bubbles from ac after spiking.Ac pump has debris or is obstructed.Defective donor needle line or donor needle connector.Incorrect venipuncture.Loading issue causing a kink/tubing line obstruction, and/or an air block a root cause assessment was performed for rbc spillover of this complaint.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: *the separation set was loaded incorrectly or is defective *line sensor is faulty.
Event or Problem Description
The customer reported that the machine allowed air bubbles to flow back toward the donor as well as allowed red cells to reach the bottle.The customer did not respond to multiple attempts to obtain information for the investigation such as patient (recipient) information, recipient outcome, procedural details and lot information.

• 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: 22337857
• Report Number: 1722028-2025-00147
• Device Sequence Number: 9160520
• Product Code: GKT
• UDI-Device Identifier: 05020583420007
• UDI-Public: 05020583420007
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup,Followup
• Report Date (Section B): 06/26/2025

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: 06/04/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 09/15/2025; 10/08/2025; 12/09/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/14/2025; 10/02/2025; 10/27/2025; 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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