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

Catalog Number	5803002
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the operator found air bubbles in the return line during the run.Luer connections were tight and there was no clotting in the channel or in the return reservoir.Per customer patient status is "nothing unusual" and no medical intervention was required.Patient id is unknown at this time the collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
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 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 that the operator found air bubbles in the return line during the run.Luer connections were tight and there was no clotting in the channel or in the return reservoir.Per customer patient status is "nothing unusual" and no medical intervention was required.Patient id is unknown at this time 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 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 customer submitted one photograph in lieu of the disposable set to aid investigation.The photo shows the inlet coil on top of the trima device and confirms the presence of air bubbles along the return line.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that the operator found air bubbles in the return line during the run.Luer connections were tight and there was no clotting in the channel or in the return reservoir.Per customer patient status is "nothing unusual" and no medical intervention was required.Patient id is unknown at this time the collection set is not available for return because it was discarded by the customer.
Event or Problem Description
The customer reported that the operator found air bubbles in the return line during the run.The luer connections were tight and there was no clotting in the channel or in the return reservoir.Per customer patient status is "nothing unusual" and no medical intervention was required.The customer declined to provide the donor's identifier.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, d4, h6 and h11.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer submitted one photograph in lieu of the disposable set to aid investigation.The photo shows the inlet coil on top of the trima device and confirms the presence of air bubbles along the return line.A disposable complaint history search was performed for this lot and found 0 reports for similar issues on this lot.The run data file (rdf) was analyzed for this event.Review of the run data file confirmed that, within the first 3 minutes of the procedure, 3 ¿draw pressure too low¿ alerts were presented.Based on the time between the second and third ¿draw pressure too low¿ alert, it is possible that the operator attempted to sterile connect a new needle while the system was in blood prime.The trima accel operator¿s manual states not to connect a new needle during blood prime due to the risk of returning air to the donor.It is possible this scenario contributed to the reported air in the return line.Other possible causes for the reported air in the donor line include, but are not limited to: air bubble from the ac line.If the drip chamber was not filled properly or if the ac bag was not connected to the bag line properly, air could have entered the ac line.During return line prime, the ac pump runs with the return pump to ensure anticoagulation of the prime blood.Otherwise, the ac pump is turned off for return cycles.The run data file shows the ac sensor did not detect air following the connection of ac, so this failure mode is unlikely unless air came from the ac line below the ac sensor.Air bubble entered from the needle line if the needle was not inserted fully into the donor vein.If the sample bag was not completely sealed, it is possible for air to have been drawn into the line from the sample bag with the donor blood.Variations in the tubing set, such as a tubing set leak or bond error.Root cause: a root cause assessment was performed for this complaint.The most likely root cause is that the operator attempted to sterile connect a new needle while the system was in blood prime.However, based on the available information, additional possible causes could not be ruled out and include: if the sample bag was not completely sealed, it is possible for air to have been drawn into the line from the sample bag with the donor blood.Variations in the tubing set, such as a tubing set leak or bond error.

• 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: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 22715946
• Report Number: 1722028-2025-00171
• Device Sequence Number: 18425038
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/05/2025

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: 5803002
• Device Lot Number: 2503084251
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 10/01/2025; 12/10/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/26/2025; 10/15/2025; 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2025
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 90 KG