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	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2026
Type of Reportable Event	Death
Event or Problem Description
The customer reported that they were notified of a donor death by the donor's ex-wife.Per the customer the event occurred off-site.The donor was removed from the device prior to the end of the plasmapheresis run.There was no medical intervention performed.  full patient identifier - (b)(6) the collection set is not available for return because it was discarded by the customer.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.7, h.6 and h.11.Investigation: the run data file (rdf) was analyzed for this event.The log file shows that over the 73-minute procedure, there were multiple access pressure alarms which are common indicators of continued access and flow issues.The ac fluid detector, donor line fluid detector, line sensor, aps, return cps, and draw cps signals were analyzed, and nothing anomalous was found.  the history of the separation set lot and plasma bottle were reviewed and there have not been any recalls for these lots.A terumo bct service technician checked out the device at the customer site and completed a functional checkout and the investigation concluded that the device was working as intended.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.Additional medical information was received and confirmed the cause of death is due to cardiovascular disease.Additionally, per the autopsy, the donor has a history of cardiovascular disease.No further reporting will be provided as this does not represent a reportable event.   .
Additional Manufacturer Narrative
This report is being filed to provide additional information in g.1, h.6 and h.11.Investigation: the run data file (rdf) was analyzed for this event.The log file shows that over the 73-minute procedure, there were multiple access pressure alarms which are common indicators of continued access and flow issues.The ac fluid detector, donor line fluid detector, line sensor, aps, return cps, and draw cps signals were analyzed, and nothing anomalous was found.  the history of the separation set lot and plasma bottle were reviewed and there have not been any recalls for these lots.A terumo bct service technician checked out the device at the customer site and completed a functional checkout and the investigation concluded that the device was working as intended.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that they were notified of a donor death by the donor's ex-wife.Per the customer the event occurred off-site.The donor was removed from the device prior to the end of the plasmapheresis run.There was no medical intervention performed.  full patient identifier - (b)(6) the collection set is not available for return because it was discarded by the customer.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.
Event or Problem Description
The customer reported that they were notified of a donor death by the donor's ex-wife.Per the customer the event occurred off-site.The donor was removed from the device prior to the end of the plasmapheresis run.There was no medical intervention performed.Full patient identifier (b)(6).The collection set is not available for return because it was discarded by the customer.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.

• 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: kristi edgington ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 25621316
• Report Number: 1722028-2026-00087
• Device Sequence Number: 18675675
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 6212001
• Device Lot Number: 2603272161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Supplement Date Received by Manufacturer: 08/13/2026; 09/01/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 08/13/2026; 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2026
• 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; Death
• Patient Age: 63 YR
• Patient Sex: Male