MAUDE Adverse Event Report: Terumo BCT Trima Accel; ACCEL PLT,PLASMA,ISBT

Catalog Number	5803003
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported that after the procedure finished the donor fainted and fell after getting off the machine to use the restroom resulting in a serious head injury.The donor was subsequently transferred to a hospital for further medical treatment.Additional follow up confirmed that medical intervention involved the use of hemostatic agents, dehydration therapy, anti-epileptic medications, and nutritional intravenous infusions.The customer declined to provide the patient identifier.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event. a root cause assessment was performed for this complaint.A definitive root cause for the donor's reaction could not be determined from dlog analysis. the available information indicates that the donor¿s actual height and weight were 163 cm and 81 kg, respectively; however, the operator entered 170 cm and 80 kg into the system.As a result, trima accel used a calculated total blood volume that was 3.80% higher than the donor¿s actual total blood volume.Review of the run data file showed that the platelet valve opened at 9 minutes and platelets exited as expected.The trima accel device reported a total ac volume of 326 ml: 227 ml returned to the donor, 81 ml in the platelet product, 5 ml in the plasma product, and 13 ml remaining in the kit.Due to the aborted plasma rinseback, approximately 13% of the donor¿s actual total blood volume was collected as product volume or remained as residual blood in the tubing kit.Run data file analysis indicated that all monitored signals were within expected ranges and that the device operated within its defined safety limits. based on clinical feedback,possible causes for the alleged reaction include but are not limited to donor's physiology and/or donor's sensitivity to the procedure.A review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process, a follow-up report will be provided.

• Brand Name: Trima Accel
• Common Device Name: ACCEL PLT,PLASMA,ISBT
• 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: 50897962
• Report Number: 1722028-2026-00125
• Device Sequence Number: 5829437
• Product Code: GKT
• UDI-Device Identifier: 05020583803008
• UDI-Public: 05020583803008
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 5803003
• Device Lot Number: 2605154151
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2026
• 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
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 178 LB