MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLT,PLASMA,ISBT

Catalog Number	5803003
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported air bubbles in the tubing line during the prime of the tubing set.The air bubbles could not be removed.Donor information and outcome are unknown at this time.The platelet collection is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported air bubbles in the tubing line during the prime of the tubing set.The air bubbles could not be removed.They stated also that all luer connections were tight and the sample bag was not inflated with air.Donor information is unknown at this time.Per customer "donor had not yet been connected." the platelet collection 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 b.5, e.1, h.6 and h.11.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.During ac priming, it is normal to observe some air bubbles in the draw and return lines.During blood priming, air bubbles present in the draw line are redirected to the channel, while air bubbles in the return line are redirected to the return reservoir.However, review of the available image showed a greater amount of air than expected in the draw, return, and ac lines.Review of the available picture confirmed the presence of air in the draw, return and ac line.Analysis of the run data file did not identify a definitive root cause for the presence of air bubbles.Possible causes are, but are not limited to: the ac spike may not have been properly inserted into the ac bag.After spike insertion, the drip chamber may not have been primed correctly (e.G., not squeezed or not maintained in a vertical position), allowing air to mix with the ac solution and enter the tubing.This is consistent with on-site photos showing significant air in the ac tube below the ac tubing spike may have been damaged, allowing external air to enter the tubing.It cannot be ruled out that the ac pump header tubing may have been misloaded in the pump raceway.The customer submitted one photograph in lieu of the disposable set to aid investigation.The photo shows the the inlet coil and confirms the presence of air bubbles in the inlet and return lines, and one small bubble in the ac line.Investigation is in process.A follow-up report will be provided.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA 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: verenia oliver ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 24247019
• Report Number: 1722028-2026-00025
• Device Sequence Number: 9657950
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2026

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: 5803003
• Device Lot Number: 2508194251
• 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: 01/11/2026
• Supplement Date Received by Manufacturer: 03/05/2026; 05/14/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/24/2026; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2025
• 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 Sex: Unknown