MAUDE Adverse Event Report: TERUMO BCT 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	05/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that the rika device alarmed 1012 volume discrepancy and a large amount of air bubbles about 12 inches was about to be infused into the donor.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.
Event or Problem Description
The customer reported that the rika device alarmed 1012 volume discrepancy and a large amount of air bubbles about 12 inches was about to be infused into the donor.Patient information and outcome are unknown at this time.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 h.6 and h.11.Investigation: a terumo bct service technician checked out the device at the customer site.The service technician followed the troubleshooting steps for alarm 1012 and was successful as well as performed the ac pump, soft cassette housing, draw pump, and return pump auto-test and received passing results.Device is operating as intended.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.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: a terumo bct service technician checked out the device at the customer site.The service technician followed the troubleshooting steps for alarm 1012 and was successful as well as performed the ac pump, soft cassette housing, draw pump, and return pump auto-test and received passing results.Device is operating as intended.The device serial number history report indicates no further related issues have been reported for this device.The lot number was not provided therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.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.Root cause: a root cause assessment was performed for 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.
Event or Problem Description
The customer reported that the rika device alarmed 1012 volume discrepancy and a large amount of air bubbles about 12 inches was about to be infused into the donor.Patient information and outcome are unknown.The collection set is not available for return because it was discarded by the customer.

• Brand Name: RIKA PLASMA DONATION SYSTEM
• 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: 22091428
• Report Number: 1722028-2025-00136
• Device Sequence Number: 15459304
• 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): 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): 05/27/2025

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: 05/03/2025
• Supplement Date Received by Manufacturer: 07/15/2025; 08/29/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 08/07/2025; 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2024
• 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