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

Catalog Number 82383

Device Problems Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

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

Event Date 05/02/2022

Event Type  malfunction  

Event Description

The customer would like the run data file investigated to determine a possible cause for the overflow of red blood cells (rbc) into the platelet concentrate when the additive solution was added.There was not a transfusion recipient or patient involved at the time of the pas addition, therefore no patient information is reasonably known at the time of the event.The platelet 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

Investigtion: one used trima set was received for investigation.Initial observations noted the ac and saline bags, and the product bags were rf sealed and removed prior to return.Visual inspection noted blood up to and in the channel, reservoir and vent bag.Red fluid is observed in the plasma line through the cassette, and in the platelet line through cassette and platelet tubing from centrifuge, above the mini pinch clamp.The mini pinch clamps are noted on the correct lines and in the closed position.The set was inspected for any kinks, misassemblies or missing parts and none were found.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 of red blood cells (rbc) into the platelet concentrate when the additive solution was added.There was not a transfusion recipient or patient involved at the time of the pas addition, therefore no patient information is reasonably known at the time of the event.The platelet 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.Investigtion: one used trima set was received for investigation.Initial observations noted the ac and saline bags, and the product bags were rf sealed and removed prior to return.Visual inspection noted blood up to and in the channel, reservoir and vent bag.Red fluid is observed in the plasma line through the cassette, and in the platelet line through cassette and platelet tubing from centrifuge, above the mini pinch clamp.The mini pinch clamps are noted on the correct lines and in the closed position.The set was inspected for any kinks, misassemblies or missing parts and none were found.The run data file (rdf) was analyzed for this event.The analysis of the run data file during the pas addition phase showed rbcs consistently passed the rbc detector from the beginning of the process.This can happen if one or more of the 3 channel clamps are left pen or if partial occluded during the pas addition phase.If these claps are not fully occluding the channel line, fluid from the channel containing rbcs and wbcs, is pulled up and can enter the product bags causing the product to turn pink or red.It is probably that the contamination of the product happened during the post-collection process.There are two verifications in place that check the status of the channel clamps.One is active during prime of the pas solution and uses the return reservoir volume to confirm if the clamps are closed.The verification during the addition phase is based on a change of the rbc detector reading.If the reading increases too much beyond the baseline, then an alert is generated.At all times during the pas addition, the tests were in place but as the volume discrepancy was not triggered, the system used the existing baseline which upon pas addition did not recognize the additional rbcs in the line.This indicates that one or more of the 3 channel lines were partially clamped and not fully occluded from the beginning of pas addition.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: the analysis of the run data file during the pas addition phase showed rbcs consistently passed the rbc detector from the beginning of the process.This can happen if one or more of the 3 channel clamps are left pen or if partial occluded during the pas addition phase.If these claps are not fully occluding the channel line, fluid from the channel containing rbcs and wbcs, is pulled up and can enter the product bags causing the product to turn pink or red.It is probably that the contamination of the product happened during the post-collection process.There are two verifications in place that check the status of the channel clamps.One is active during prime of the pas solution and uses the return reservoir volume to confirm if the clamps are closed.The verification during the addition phase is based on a change of the rbc detector reading.If the reading increases too much beyond the baseline, then an alert is generated.At all times during the pas addition, the tests were in place but as the volume discrepancy was not triggered, the system used the existing baseline which upon pas addition did not recognize the additional rbcs in the line.This indicates that one or more of the 3 channel lines were partially clamped and not fully occluded from the beginning of pas addition.

Event Description

The customer would like the run data file investigated to determine a possible cause for the overflow of red blood cells (rbc) into the platelet concentrate when the additive solution was added.There was not a transfusion recipient or patient involved at the time of the pas addition, therefore no patient information is reasonably known at the time of the event.The platelet 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 b.6 and h.10.Investigtion: one used trima set was received for investigation.Initial observations noted the ac and saline bags, and the product bags were rf sealed and removed prior to return.Visual inspection noted blood up to and in the channel, reservoir and vent bag.Red fluid is observed in the plasma line through the cassette, and in the platelet line through cassette and platelet tubing from centrifuge, above the mini pinch clamp.The mini pinch clamps are noted on the correct lines and in the closed position.The set was inspected for any kinks, misassemblies or missing parts and none were found.The run data file (rdf) was analyzed for this event.The analysis of the run data file during the pas addition phase showed rbcs consistently passed the rbc detector from the beginning of the process.This can happen if one or more of the 3 channel clamps are left pen or if partial occluded during the pas addition phase.If these claps are not fully occluding the channel line, fluid from the channel containing rbcs and wbcs, is pulled up and can enter the product bags causing the product to turn pink or red.It is probably that the contamination of the product happened during the post-collection process.There are two verifications in place that check the status of the channel clamps.One is active during prime of the pas solution and uses the return reservoir volume to confirm if the clamps are closed.The verification during the addition phase is based on a change of the rbc detector reading.If the reading increases too much beyond the baseline, then an alert is generated.At all times during the pas addition, the tests were in place but as the volume discrepancy was not triggered, the system used the existing baseline which upon pas addition did not recognize the additional rbcs in the line.This indicates that one or more of the 3 channel lines were partially clamped and not fully occluded from the beginning of pas addition.Investigation is in process.A follow up report will be provided.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA LRS PLT W/FILTER+SAMPLER+AUTO
• 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: 14645323
• MDR Text Key: 301358354
• Report Number: 1722028-2022-00192
• 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
• Report Date: 06/09/2022

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 Expiration Date: 05/01/2023
• Device Catalogue Number: 82383
• Device Lot Number: 2105252130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 06/15/2022; 06/15/2022
• Supplement Dates FDA Received: 07/01/2022; 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2021
• 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