MAUDE Adverse Event Report: TERUMO BCT RIKA; RIKA PLASMA SEPARATION SET

Catalog Number	6212001
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	08/11/2025
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 bubbles were identified in the donor line near soft cassette and the donation was immediately ended.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 a.2, a.3a, a.4, b.5, h.6 and h.11.The run data file (rdf) was analyzed for this event.The donor line fluid detector briefly reported air during blood prime and intermittently during the first 4 draw cycles.The donor fluid detector did not report air during any of the return cycles in this run.The ac fluid detector did not detect air at any point during the run.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that bubbles were identified in the donor line near soft cassette and the donation was immediately ended.Patient identifier is unknown at this time.Per the customer the "donor is currently qualified with no active deferrals, they have not donated since the event" and no medical intervention was required for this event.No additional information is known.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.Investigation: the run data file (rdf) was analyzed for this event.The donor line fluid detector briefly reported air during blood prime and intermittently during the first 4 draw cycles.The donor fluid detector did not report air during any of the return cycles in this run.The ac fluid detector did not detect air at any point during the run.The device serial number history report indicates no further related issues have been reported for this device.A disposable complaint history search was performed for this lot and found 2 reports for similar issues on this lot.See mdr 1722028-2025-00209 and 1722028-2025-00210.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that bubbles were identified in the donor line near soft cassette and the donation was immediately ended.Full collection id: (b)(4) per the customer the "donor is currently qualified with no active deferrals, they have not donated since the event" and no medical intervention was required for this event.The customer indicated on follow-up that air was observed in the tubing on the donor side of the soft cassette.All the luer connections were tight.It was not known if there was clotting in the channel or in the return chamber because nothing was noted by the operator during the case creation.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 a.1, b.5, h.6 and h.11.Investigation: the run data file (rdf) was analyzed for this event.The donor line fluid detector briefly reported air during blood prime and intermittently during the first 4 draw cycles.The donor fluid detector did not report air during any of the return cycles in this run.The ac fluid detector did not detect air at any point during the run.The device serial number history report indicates no further related issues have been reported for this device.A disposable complaint history search was performed for this lot and found 2 reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that bubbles were identified in the donor line near soft cassette and the donation was immediately ended.Full collection id:(b)(6) per the customer the "donor is currently qualified with no active deferrals, they have not donated since the event" and no medical intervention was required for this event.No additional information is known.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, d.4, h.6 and h.11.Investigation: the run data file (rdf) was analyzed for this event.The donor line fluid detector briefly reported air during blood prime and intermittently during the first 4 draw cycles.The donor fluid detector did not report air during any of the return cycles in this run.The ac fluid detector did not detect air at any point during the run.The device serial number history report indicates no further related issues have been reported for this device.A disposable complaint history search was performed for this lot and found 2 reports for similar issues on this lot.See mdr 1722028-2025-00209 and 1722028-2025-00210.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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 bubbles were identified in the donor line near soft cassette and the donation was immediately ended.Full collection id: (b)(6) per the customer the "donor is currently qualified with no active deferrals, they have not donated since the event" and no medical intervention was required for this event.The customer indicated on follow-up that air was observed in the tubing on the donor side of the soft cassette.All the luer connections were tight.It was not known if there was clotting in the channel or in the return chamber because nothing was noted by the operator during the case creation.There was no medical intervention.The collection set is not available for return because it was discarded by the customer.

• Brand Name: RIKA
• Common Device Name: RIKA PLASMA SEPARATION SET
• 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: 22979569
• Report Number: 1722028-2025-00210
• Device Sequence Number: 9391370
• Product Code: GKT
• UDI-Device Identifier: 05020583212008
• UDI-Public: 05020583212008
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/05/2025

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 Catalogue Number: 6212001
• Device Lot Number: 2505132161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 10/30/2025; 11/14/2025; 12/11/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/21/2025; 11/13/2025; 12/08/2025; 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Male