MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT SAMPLER AUTOPAS MULTIPLS SET

Catalog Number 80310

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

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

Event Date 10/25/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer the clamps were closed correctly.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 white blood cell (rwbc) testing, 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.The wbc count is not available, at this time.

Manufacturer Narrative

This report is being filed to provide additional information in g.2, h.6 and h.10 and corrected information in e.1 and e.3.Root cause : during the pas solution prime phase, the return reservoir volume is used to confirm the correct closing of the channel line clamps.A "channel line clamp error" is generated when the return pump processed 6 ml before the lower level reservoir sensor detected air.Possible causes for this alert are, but are not limited to: channel line clamps not closed correctly.Additive solution connected too early.Return pump occlusion error during the pas addition phase, the device monitors the correct closing of the channel line clamps.A "channel line clamp error" is generated when the device cannot verify that the channel lines are completely occluded.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¿ alert 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.

Manufacturer Narrative

Investigation : 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.It was confirmed that the device flagged the run for potential contamination.The run data file (rdf) was analyzed for this event.When a ¿channel line clamp error¿ alert is generated during the solution prime phase, it is recommended to verify that the lines coming from the centrifuge are fully occluded by the channel line clamps.It is advised to move the clamps slightly forward and backwards ensuring the line is positioned in the center of the clamp before closing.It is advised to follow all screen prompts, this to avoid an early connection of the pas solution bag.When a ¿channel line clamp error¿ alert is generated during the pas addition phase, it is recommended to verify that the lines coming from the centrifuge are fully occluded by the channel line clamps.It is advised to move the clamp slightly forward and backwards ensuring the line is positioned in the center of the clamp before closing.It may be useful to remind operators regarding the correct procedure for breaking the frangible connector on the platelet additive solution bag.Break the frangible connector completely by bending the connector back and forth several times.Ensure that the frangible connector is thoroughly broken to ensure proper flow.The frangible is completely severed when it "floats" freely within the frangible connector assembly.Directly following pas connection, it is also advised to verify that -the frangible of the platelet additive solution bag is fully broken and does not reseat -the filter on the pas line is correctly primed -the yellow line on the pas line is completely open an incomplete cleaning of the cassette may be caused by insufficient pas flow or one or more of the 3 channel lines were partially clamped and not fully occluded.It is as well recommended to visually verify the correct cleaning of the cassette prior to add the platelet additive solution to the platelet bag.In case the cassette is not correctly cleaned, it is possible to end prematurely the platelet additive solution addition by selecting ¿end addition¿.The trima accel device will display the amount of platelet additive solution for manual addition to the platelet product.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 Description

Per the customer, the unit was not tested, the unit disqualified.The wbc count is not available.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLT SAMPLER AUTOPAS MULTIPLS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10855090
• MDR Text Key: 220981493
• Report Number: 1722028-2020-00512
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2020

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: 04/01/2022
• Device Catalogue Number: 80310
• Device Lot Number: 2004281230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/25/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 11/20/2020; 12/12/2020
• Supplement Dates FDA Received: 12/09/2020; 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other