MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA LRS PLT W/FILTER+SAMPLER+AUTOPAS

Catalog Number 4823832

Device Problems Device Misassembled During Manufacturing /Shipping (2912); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process, a follow-up report will be provided.

Event Description

The customer would like the run data file investigated to determine a possible cause for the overflow into the platelet concentrate when the additive solution was added.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.The wbc count is not available at this time the collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Investigation: a photograph was submitted in lieu of the disposable set to aid in the investigation.Analysis of the images revealed a used trima cassette assembly.It was confirmed that the small pinch clamp assembled in the platelet line was wrongly positioned, rendering it unable to occlude the tubing.The run data file (rdf) was analyzed for this event.The trima accel device has software algorithms that use the rbc detector output to monitor and flag if an rbc spillover occurs during pas addition.Analysis of the 3 run data files confirmed these algorithms were monitoring at all times during the pas addition process, however the reported rbcs were not detected and therefore no alerts were triggered.Run data file analysis did not show any rbc contamination at the rbc detector during the automatic pas addition process.Review of signals at the rbc detector during the automatic pas addition process showed that the cassette was cleaned correctly, and the pas fluid added to the platelet bag(s) appeared clear.The root cause for the reported rbc contamination during the automatic pas addition process could not be determined from the dlog analysis.Possible causes for rbcs entering the platelet product bag during pas addition include, but are not limited to: - ineffective cassette cleaning during the pas priming process where the system cannot identify a change in the signal to detect passing rbcs - platelet and/or plasma channel line clamps may not have been fully occluding the channel lines, allowing fluid from the channel containing rbcs to be pulled up into the platelet product bags - inadequate pas fluid connection, causing any rbc contents within the cassette to enter the platelet product bags - incorrectly primed filter on the pas line - pas bag frangible not broken correctly or reseated - yellow clamp on the pas line not opened fully the device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Investigation is in process, a follow-up report will be provided.

Event Description

The customer would like the run data file investigated to determine a possible cause for the overflow into the platelet concentrate when the additive solution was added.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.The wbc count is not available at this time the collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Investigation: a photograph was submitted in lieu of the disposable set to aid in the investigation.Analysis of the images revealed a used trima cassette assembly.It was confirmed that the small pinch clamp assembled in the platelet line was wrongly positioned, rendering it unable to occlude the tubing.The run data file (rdf) was analyzed for this event.The trima accel device has software algorithms that use the rbc detector output to monitor and flag if an rbc spillover occurs during pas addition.Analysis of the 3 run data files confirmed these algorithms were monitoring at all times during the pas addition process, however the reported rbcs were not detected and therefore no alerts were triggered.Run data file analysis did not show any rbc contamination at the rbc detector during the automatic pas addition process.Review of signals at the rbc detector during the automatic pas addition process showed that the cassette was cleaned correctly, and the pas fluid added to the platelet bag(s) appeared clear.The root cause for the reported rbc contamination during the automatic pas addition process could not be determined from the dlog analysis.Possible causes for rbcs entering the platelet product bag during pas addition include, but are not limited to: - ineffective cassette cleaning during the pas priming process where the system cannot identify a change in the signal to detect passing rbcs - platelet and/or plasma channel line clamps may not have been fully occluding the channel lines, allowing fluid from the channel containing rbcs to be pulled up into the platelet product bags - inadequate pas fluid connection, causing any rbc contents within the cassette to enter the platelet product bags - incorrectly primed filter on the pas line - pas bag frangible not broken correctly or reseated - yellow clamp on the pas line not opened fully the device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Root cause: a root cause assessment was performed for this complaint.Based on the picture evaluation the root cause of the failure was due to the platelet channel line clamps were not have been fully occluding the channel lines, due to manufacturing misassembly, allowing fluid from the channel containing rbcs to be pulled up into the platelet product bags.The trima accel device has software algorithms that use the rbc detector output to monitor and flag if an rbc spillover occurs during pas addition.Analysis of the 3 run data files confirmed these algorithms were monitoring at all times during the pas addition process, however the reported rbcs were not detected and therefore no alerts were triggered.Run data file analysis did not show any rbc contamination at the rbc detector during the automatic pas addition process.Review of signals at the rbc detector during the automatic pas addition process showed that the cassette was cleaned correctly, and the pas fluid added to the platelet bag(s) appeared clear.

Event Description

The customer would like the run data file investigated to determine a possible cause for the overflow into the platelet concentrate when the additive solution was added.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.The wbc count is not available.The collection set is not available for return because it was discarded by the customer.After multiple follow-up attempts, no additional information was available from the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Event Description

The customer would like the run data file investigated to determine a possible cause for the overflow into the platelet concentrate when the additive solution was added.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.The wbc count is not available at this time the collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: a photograph was submitted in lieu of the disposable set to aid in the investigation.Analysis of the images revealed a used trima cassette assembly.It was confirmed that the small pinch clamp assembled in the platelet line was wrongly positioned, rendering it unable to occlude the tubing.The run data file (rdf) was analyzed for this event.The trima accel device has software algorithms that use the rbc detector output to monitor and flag if an rbc spillover occurs during pas addition.Analysis of the 3 run data files confirmed these algorithms were monitoring at all times during the pas addition process, however the reported rbcs were not detected and therefore no alerts were triggered.Run data file analysis did not show any rbc contamination at the rbc detector during the automatic pas addition process.Review of signals at the rbc detector during the automatic pas addition process showed that the cassette was cleaned correctly, and the pas fluid added to the platelet bag(s) appeared clear.The root cause for the reported rbc contamination during the automatic pas addition process could not be determined from the dlog analysis.Possible causes for rbcs entering the platelet product bag during pas addition include, but are not limited to: - ineffective cassette cleaning during the pas priming process where the system cannot identify a change in the signal to detect passing rbcs - platelet and/or plasma channel line clamps may not have been fully occluding the channel lines, allowing fluid from the channel containing rbcs to be pulled up into the platelet product bags - inadequate pas fluid connection, causing any rbc contents within the cassette to enter the platelet product bags - incorrectly primed filter on the pas line - pas bag frangible not broken correctly or reseated - yellow clamp on the pas line not opened fully investigation is in process, a follow-up report will be provided.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA LRS PLT W/FILTER+SAMPLER+AUTOPAS
• 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: 18511210
• MDR Text Key: 333538746
• Report Number: 1722028-2024-00024
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/15/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 4823832
• Device Lot Number: 2305242142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/15/2024
• Supplement Dates Manufacturer Received: 01/30/2024; 02/13/2024; 04/11/2024
• Supplement Dates FDA Received: 02/09/2024; 03/05/2024; 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other