MAUDE Adverse Event Report: Terumo BCT Rika; RIKA PLASMA SEPARATION SET

Catalog Number	6212001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2026
Type of Reportable Event	Death
Event or Problem Description
The customer reported that following a plasmapheresis procedure on (b)(6) 2026 using a rika device, the donor was found deceased on (b)(6) 2026.The collection set is not available for return because it was discarded by the customer.This report is being filed due to a reported patient death.At this time, the available information does not indicate a detectable malfunction of the terumo bct device, and no device malfunction has been alleged.
Event or Problem Description
The customer reported that following a plasmapheresis procedure on (b)(6) 2026 using a rika device, the donor was found deceased on (b)(6) 2026.The collection set is not available for return because it was discarded by the customer.This report is being filed due to a reported patient death.At this time, the available information does not indicate a detectable malfunction of the terumo bct device, and no device malfunction has been alleged.
Additional Manufacturer Narrative
Investigation: a service technician checked out the device at the customer site and concluded that the device performed as expected with passing results. 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.Investigation: a service technician checked out the device at the customer site and concluded that the device performed as expected with passing results.  the run data file (rdf) was analyzed for this event.The log file shows that over the 37-minute procedure, there was one 4602 access pressure too low alarm in the 6th draw cycle, which the operator was able to continue.The ac fluid detector, donor line fluid detector, line sensor, aps, return cps, and draw cps signals were analyzed, and nothing anomalous was found.  a review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.The history of the separation set lot 2604243161 and plasma bottle 2603041002 were reviewed and there have not been any recalls for these lots.Investigation is in process, a follow-up report will be provided.

• 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: kristi edgington ; 10810 w collins ave; lakewood, CO 80215
• MDR Report Key: 50303450
• Report Number: 1722028-2026-00119
• Device Sequence Number: 10688212
• Product Code: GKT
• UDI-Device Identifier: 05020583212008
• UDI-Public: 05020583212008
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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: 2604243161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2026
• 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: Death; Other
• Patient Sex: Male