MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLATELET+SAMPLER, PLASMA, RBC SET

Model Number	3810002
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	10/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer called to request service for the heat sealer on the trima device as the sealer was melting the tubing.The sealer caused a blood leak on the platelet bag tubing, resulting in a blood exposure.The operator was sprayed on the mouth with the donor's blood.The exposed person was sent to the emergency room for routine testing and treatment.Per the donation center, the donors blood will be tested per protocol.The technician age, gender, weight and outcome are not available at this time.Donor unit id: (b)(6).
Event or Problem Description
The customer called to request service for the heat sealer on the trima device as the sealer was melting the tubing.The sealer caused a blood leak on the platelet bag tubing, resulting in a blood exposure.The operator was sprayed on the mouth with the donor's blood.The exposed person was sent to the emergency room for routine testing and treatment.Per the donation center, the donors blood will be tested per protocol.The technician age, gender, weight and outcome are not available at this time.Donor unit id: (b)(4).
Additional Manufacturer Narrative
Investigation: a service technician checked out the device at the customer site.The technician tested the sealer and found that it was functioning and producing seals.As a proactive measure, the technician replaced both the sealer and the rf cable.After replacement, the sealer was tested again and verified to be sealing properly.The technician ensured that the splash guard was correctly installed on the seal head and demonstrated to the unit manager how to properly position the splash guard.Additional replacement splash guards were provided to the manager.The machine was then returned to the customer for use.One sealer cutter was evaluated.Visual inspection: splash guard present and in good shape.Jaws have a small gap from end to end when handles are squeezed together.Upper and lower jaw surfaces are dirty.Several welds acceptable welds were made with dry and fluid filled tubing.Difficult to break welds resulting from the jaws not touching when closed.The tear groove is difficult to break but is centered within weld.Per this evaluation, the reported issue of weld falling apart was not verified one year of service history was reviewed for this device with no further issues related to the reported condition identified.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer called to request service for the heat sealer on the trima device as the sealer was melting the tubing.The sealer caused a blood leak on the platelet bag tubing, resulting in a blood exposure.The operator was sprayed on the mouth with the donor's blood.The exposed person was sent to the emergency room for routine testing and treatment.Per the donation center, the donors blood will be tested per protocol.The technician age, gender, weight and outcome are not available at this time.Donor unit id: (b)(4).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 b5, d2a, d4, d9, g1, h4, h5, h6, h8, and h11.Investigation: a service technician checked out the device at the customer site.The technician tested the sealer and found that it was functioning and producing seals.As a proactive measure, the technician replaced both the sealer and the rf cable.After replacement, the sealer was tested again and verified to be sealing properly.The technician ensured that the splash guard was correctly installed on the seal head and demonstrated to the unit manager how to properly position the splash guard.Additional replacement splash guards were provided to the manager.The machine was then returned to the customer for use.One sealer cutter was evaluated.Visual inspection: splash guard present and in good shape.Jaws have a small gap from end to end when handles are squeezed together.Upper and lower jaw surfaces are dirty.Several welds acceptable welds were made with dry and fluid filled tubing.Difficult to break welds resulting from the jaws not touching when closed.The tear groove is difficult to break but is centered within weld.Per this evaluation, the reported issue of weld falling apart was not verified one year of service history was reviewed for this device with no further issues related to the reported condition identified.A review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.Correction: the regional sales representative contacted the customer regarding this incident with an offer of retraining.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer called to request service for the heat sealer on the trima device as the sealer was melting the tubing.The sealer caused a blood leak on the platelet bag tubing, resulting in a blood exposure.The operator was sprayed on the mouth with the donor's blood.The exposed person was sent to the emergency room for routine testing and treatment.Per the donation center, the donors blood will be tested per protocol.The technician age, gender, weight and outcome are not available at this time.Donor unit id: w121625319915 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  g.1, h.6, and h.11 investigation: a service technician checked out the device at the customer site. the technician tested the sealer and found that it was functioning and producing seals.As a proactive measure, the technician replaced both the sealer and the rf cable.After replacement, the sealer was tested again and verified to be sealing properly.The technician ensured that the splash guard was correctly installed on the seal head and demonstrated to the unit manager how to properly position the splash guard.Additional replacement splash guards were provided to the manager.The machine was then returned to the customer for use. one sealer cutter was evaluated. visual inspection: splash guard present and in good shape.Jaws have a small gap from end to end when handles are squeezed together.Upper and lower jaw surfaces are dirty.Several welds acceptable welds were made with dry and fluid filled tubing. difficult to break welds resulting from the jaws not touching when closed.The tear groove is difficult to break but is centered within weld.Per this evaluation, the reported issue of weld falling apart was not verified one year of service history was reviewed for this device with no further issues related to the reported condition identified.A review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.Correction: the regional sales representative contacted the customer regarding this incident with an offer of retraining.Root cause: a root cause assessment was performed for this complaint.Based on the service report, the seal safe was found to be operating as intended, therefore the most likely root cause was due to operator use and/or the improper or missing placement of the splash guard.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA PLATELET+SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: verenia oliver ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 23842899
• Report Number: 1722028-2025-00277
• Device Sequence Number: 18631416
• Product Code: GKT
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: BK190332
• 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,Followup,Followup,Followup
• Report Date (Section B): 12/18/2025

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 Model Number: 3810002
• Device Catalogue Number: 4824462
• Device Lot Number: 2507312242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 02/17/2026; 03/24/2026; 05/28/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/26/2026; 04/16/2026; 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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: Required Intervention
• Patient Sex: Unknown