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

Catalog Number 82383

Device Problems Contamination of Device Ingredient or Reagent (2901); No Apparent Adverse Event (3189)

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

Event Date 06/18/2022

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 of red blood cells (rbc) into the platelet concentrate when the additive solution was added.Per the customer, the product was used.Donation number: (b)(4) patient information and outcome are not available at this time.Wbc count is not available as the product was not tested.Terumo bct is awaiting the return of the set for evaluation.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 of red blood cells (rbc) into the platelet concentrate when the additive solution was added.Per the customer, the product was used.Donation number: (b)(6).Patient information and outcome are not available at this time.Wbc count is not available as the product was not tested.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: one used trima set was received for investigation.Initial observations noted the ac and product bags were rf sealed and removed prior to return.Blood was noted in the left hand side of the set including in the channel and the reservoir.Red cells were also observed in the platelet line from centrifuge, in the platelet line through the cassette and over the rbc detector, in the platelet pump header tubing and recirc lines.The mini pinch clamps were noted to be on the correct lines and in the closed position.They were tight on the lines and appeared to be occluding the tubing.The set was inspected for any kinks, missing part or misassemblies and none were found.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.The run data file (rdf) was analyzed for this event.Review of the rbc signal during platelet additive solution phase showed the cassette was not cleaned properly and that the rbcs were detected by the rbc detector at the beginning of the platelet additive solution phase.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 a ¿channel line clamp error¿ is generated, as was the case in this procedure.It is possible, though not conclusive that one or more of the 3 channel lines were partially clamped and not fully occluded, or the frangible of the platelet additive solution bag was not fully broken or reseated.The procedure is flagged for potential wbc contamination.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: one used trima set was received for investigation.Initial observations noted the ac and product bags were rf sealed and removed prior to return.Blood was noted in the left hand side of the set including in the channel and the reservoir.Red cells were also observed in the platelet line from centrifuge, in the platelet line through the cassette and over the rbc detector, in the platelet pump header tubing and recirc lines.The mini pinch clamps were noted to be on the correct lines and in the closed position.They were tight on the lines and appeared to be occluding the tubing.The set was inspected for any kinks, missing part or misassemblies 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.Per the customer, the product was used.Donation number: (b)(6).Patient information and outcome are not available at this time.Wbc count is not available as the product was not tested.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 of red blood cells (rbc) into the platelet concentrate when the additive solution was added.Per the customer, the product was used.Donation number: (b)(6) patient information and outcome are not available at this time.Wbc count is not available as the product was not tested.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: one used trima set was received for investigation.Initial observations noted the ac and product bags were rf sealed and removed prior to return.Blood was noted in the left hand side of the set including in the channel and the reservoir.Red cells were also observed in the platelet line from centrifuge, in the platelet line through the cassette and over the rbc detector, in the platelet pump header tubing and recirc lines.The mini pinch clamps were noted to be on the correct lines and in the closed position.They were tight on the lines and appeared to be occluding the tubing.The set was inspected for any kinks, missing part or misassemblies and none were found.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.The run data file (rdf) was analyzed for this event.Review of the rbc signal during platelet additive solution phase showed the cassette was not cleaned properly and that the rbcs were detected by the rbc detector at the beginning of the platelet additive solution phase.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 a ¿channel line clamp error¿ is generated, as was the case in this procedure.It is possible, though not conclusive that one or more of the 3 channel lines were partially clamped and not fully occluded, or the frangible of the platelet additive solution bag was not fully broken or reseated.The procedure is flagged for potential wbc contamination.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Signals in the run data file (rdf) indicated that the trima device operated as intended by flagging the procedure to verify wbcs.No further reporting will be provided as this does not represent a reportable event.Root cause: review of the rbc signal during platelet additive solution phase showed the cassette was not cleaned properly and that the rbcs were detected by the rbc detector at the beginning of the platelet additive solution phase.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 a ¿channel line clamp error¿ is generated, as was the case in this procedure.It is possible, though not conclusive that one or more of the 3 channel lines were partially clamped and not fully occluded, or the frangible of the platelet additive solution bag was not fully broken or reseated.The procedure is flagged for potential wbc contamination.

• 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: 15094910
• MDR Text Key: 304697671
• Report Number: 1722028-2022-00240
• 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: 07/25/2022

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: 02/01/2024
• Device Catalogue Number: 82383
• Device Lot Number: 2202161130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/25/2022
• Supplement Dates Manufacturer Received: 07/27/2022; 09/06/2022; 09/21/2022
• Supplement Dates FDA Received: 08/19/2022; 09/13/2022; 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• 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