MAUDE Adverse Event Report: TERUMO BCT RIKA PLASMA SEPARATION SET

Catalog Number	6212001
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemolysis (1886); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported potential hemolysis in the 3rd draw cycle during a plasma collection procedure.After 2 more draw cycles and 3 return cycles the device alarmed "4402: potential hemolysis detected " on the 6th draw cycle.The solutions were correctly attached and no clots were observed in the channel or channel lines.Per the customer "the set was looked at, no hemolysis observed" patient outcome unknown at this time.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.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.No further reporting will be provided as this does not represent a reportable event.
Event or Problem Description
Customer reported potential hemolysis in the 3rd draw cycle during a plasma collection procedure.After 2 more draw cycles and 3 return cycles the device alarmed "4402: potential hemolysis detected " on the 6th draw cycle.The solutions were correctly attached and no clots were observed in the channel or channel lines.Per the customer "the set was looked at, no hemolysis observed" patient outcome unknown at this time.The collection set is not available for return because it was discarded by the customer.

• Brand Name: RIKA PLASMA SEPARATION SET
• 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: 22770825
• Report Number: 1722028-2025-00177
• Device Sequence Number: 18433626
• Product Code: GKT
• UDI-Device Identifier: 05020583212008
• UDI-Public: 05020583212008
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 08/11/2025

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: 2504251161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2025
• 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: 23 YR
• Patient Sex: Male