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	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the customer submitted three photographs in lieu of the disposable set to aid investigation.One photo shows the tyvek lid confirming the ref number, (b)(4), and the lot number, 2404094151.The second photo shows the trima device screen and confirms the alarm level sensor failure, alarm number 134.The third photo shows the cassette loaded on the trima device.Blood was noted in the left-hand side of the cassette and plasma/platelets in the right-hand side.Air is observed in the return line from the reservoir to the return pump, and in the return line from the return pump header continuing into the blue striped return line.The return pump header tubing, inlet pump header tubing, and plasma pump header tubing all appear to be loaded correctly.The ac and platelet pump header tubing is not fully visible in the photo.A large clump is observed in the return reservoir filter trap.The reservoir is noted to be about 80% full.A review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found 0 reports for similar issues on this lot.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that during a plateletpheresis procedure the device alarmed with a level sensor failure and they found air in the return line.The procedure was terminated before it reached the donor.The customer stated all luer connections were tight and the blood diversion pouch was not inflated with air.The donor was connected but was not connected prior to ac prime.No air was being drawn in through the ac line or filter, and they stated there was no clotting in the channel or return reservoir.The customer declined to provide donor id.The donor was reported as safe and was sent back after observation with no issues.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: the customer submitted three photographs in lieu of the disposable set to aid investigation.One photo shows the tyvek lid confirming the ref number, (b)(4), and the lot number, 2404094151.The second photo shows the trima device screen and confirms the alarm level sensor failure, alarm number 134.The third photo shows the cassette loaded on the trima device.Blood was noted in the left hand side of the cassette and plasma/platelets in the right hand side.Air is observed in the return line from the reservoir to the return pump, and in the return line from the return pump header continuing into the blue striped return line.The return pump header tubing, inlet pump header tubing, and plasma pump header tubing all appear to be loaded correctly.The ac and platelet pump header tubing is not fully visible in the photo.A large clump is observed in the return reservoir filter trap.The reservoir is noted to be about 80% full.The run data file (rdf) was analyzed for this event.Run data file analysis confirmed alarm 134, ¿level sensor failure¿ was generated during this procedure.This alarm was generated because the first return cycle took longer than expected to empty the reservoir.Run data file analysis did not show a conclusive root cause for this long return cycle.However, in the photo provided with the complaint (img-20250424-wa0076), a suspected clot is present in the lower portion of the reservoir.If a clot forms in the lower portion of the reservoir, it can prevent the lower sensor from detecting air, leading to the return cycle proceeding longer than expected and air entering the return line.The system acted as designed in detecting this failure mode with alarm 134 and prompting the operator to terminate the procedure without rinseback.It is possible, though not conclusive, that the suspected clot in the reservoir was caused by the low flow through the access line before blood was well mixed with anticoagulant from the multiple ¿draw pressure too low¿ alerts within the first minute of the procedure.Other possible causes for a clot to form in the reservoir include, but are not limited to: blocked or partially occluded ac line.Incorrect solution attached to the ac line.Donor related phenomenon a review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found 0 reports for similar issues on this lot.Root cause: run data file analysis confirmed alarm 134, ¿level sensor failure¿ was generated during this procedure.This alarm was generated because the first return cycle took longer than expected to empty the reservoir.Run data file analysis did not show a conclusive root cause for this long return cycle.However, in the photo provided with the complaint (img-20250424-wa0076), a suspected clot is present in the lower portion of the reservoir.If a clot forms in the lower portion of the reservoir, it can prevent the lower sensor from detecting air, leading to the return cycle proceeding longer than expected and air entering the return line.The system acted as designed in detecting this failure mode with alarm 134 and prompting the operator to terminate the procedure without rinseback.It is possible, though not conclusive, that the suspected clot in the reservoir was caused by the low flow through the access line before blood was well mixed with anticoagulant from the multiple ¿draw pressure too low¿ alerts within the first minute of the procedure.Other possible causes for a clot to form in the reservoir include, but are not limited to: blocked or partially occluded ac line.Incorrect solution attached to the ac line.Donor related phenomenon.
Event or Problem Description
The customer reported that during a plateletpheresis procedure the device alarmed with a level sensor failure and they found air in the return line.The procedure was terminated before it reached the donor.The customer stated all luer connections were tight and the blood diversion pouch was not inflated with air.The donor was connected but was not connected prior to ac prime.No air was being drawn in through the ac line or filter, and they stated there was no clotting in the channel or return reservoir.The customer declined to provide donor id.The donor was reported as safe and was sent back after observation with no issues.The collection set is not available for return because it was discarded by the customer.
Event or Problem Description
The customer reported that during a plateletpheresis procedure the device alarmed with a level sensor failure and they found air in the return line.The procedure was terminated before it reached the donor.The customer stated all luer connections were tight and the blood diversion pouch was not inflated with air.The donor was connected but was not connected prior to ac prime.No air was being drawn in through the ac line or filter, and they stated there was no clotting in the channel or return reservoir.The customer declined to provide donor id.The donor was reported as safe and was sent back after observation with no issues.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 b.6, h.6 and h.11.Investigation: the customer submitted three photographs in lieu of the disposable set to aid investigation.One photo shows the tyvek lid confirming the ref number, (b)(4), and the lot number, 2404094151.The second photo shows the trima device screen and confirms the alarm level sensor failure, alarm number 134.The third photo shows the cassette loaded on the trima device.Blood was noted in the left hand side of the cassette and plasma/platelets in the right hand side.Air is observed in the return line from the reservoir to the return pump, and in the return line from the return pump header continuing into the blue striped return line.The return pump header tubing, inlet pump header tubing, and plasma pump header tubing all appear to be loaded correctly.The ac and platelet pump header tubing is not fully visible in the photo.A large clump is observed in the return reservoir filter trap.The reservoir is noted to be about 80% full.The run data file (rdf) was analyzed for this event.Run data file analysis confirmed alarm 134, ¿level sensor failure¿ was generated during this procedure.This alarm was generated because the first return cycle took longer than expected to empty the reservoir.Run data file analysis did not show a conclusive root cause for this long return cycle.However, in the photo provided with the complaint ((b)(4)), a suspected clot is present in the lower portion of the reservoir.If a clot forms in the lower portion of the reservoir, it can prevent the lower sensor from detecting air, leading to the return cycle proceeding longer than expected and air entering the return line.The system acted as designed in detecting this failure mode with alarm 134 and prompting the operator to terminate the procedure without rinseback.It is possible, though not conclusive, that the suspected clot in the reservoir was caused by the low flow through the access line before blood was well mixed with anticoagulant from the multiple ¿draw pressure too low¿ alerts within the first minute of the procedure.Other possible causes for a clot to form in the reservoir include, but are not limited to: ¿ blocked or partially occluded ac line ¿ incorrect solution attached to the ac line ¿ donor related phenomenon a review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found 0 reports for similar issues on this lot.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: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 22062615
• Report Number: 1722028-2025-00132
• Device Sequence Number: 7634410
• Product Code: GKT
• UDI-Device Identifier: 05020583803008
• UDI-Public: 05020583803008
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 05/21/2025

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 Expiration Date: 04/01/2026
• Device Catalogue Number: 5803002
• Device Lot Number: 2404094151
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 07/09/2025; 09/08/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/31/2025; 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2024
• 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: 29 YR
• Patient Sex: Male
• Patient Weight: 72 KG