MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLT, PLS, RBC SET

Catalog Number 80405

Device Problems High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Alerts that are known to contribute to wbc contamination were not generated in this run data file.As the trima system cannot count the cells entering the platelet product bag, the rbc detector signals must see a significant change in the reflectance values to notify the operator of an lrs chamber saturation and to count the wbcs in the platelet product.In this case, the signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data file reported that the platelet product could be labeled as leukoreduced.Although the trima system has several methods for detection of possible wbc contamination, it is possible that some events may elude the detection capability of the trima system.Run data file analysis did not show a conclusive root cause for the elevated wbc content in the platelet product reported for this collection.However, it is possible, though not conclusive, that wbcs may have escaped the lrs chamber late in the procedure where the run completed before the system could detect the contamination.Based on the available information, it is possible this failure may be related to donor specific blood characteristics that may challenge the trima leukoreduction system, including, but not limited to higher than average donor pre-mnc and/or pre- wbc counts or the high donor bmi.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 elevated white blood cell (wbc) content in the platelet product.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.

Manufacturer Narrative

This report is being filed to provide additional information in e.1, e.3, h.6 and h.10.Corrected information is provided in e.1.Investigation: 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.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Root cause: alerts that are known to contribute to wbc contamination were not generated in this run data file.As the trima system cannot count the cells entering the platelet product bag, the rbc detector signals must see a significant change in the reflectance values to notify the operator of an lrs chamber saturation and to count the wbcs in the platelet product.In this case, the signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data file reported that the platelet product could be labeled as leukoreduced.Although the trima system has several methods for detection of possible wbc contamination, it is possible that some events may elude the detection capability of the trima system.Run data file analysis did not show a conclusive root cause for the elevated wbc content in the platelet product reported for this c ollection.However, it is possible, though not conclusive, that wbcs may have escaped the lrs chamber late in the procedure where the run completed before the system could detect the contamination.Based on the available information, it is possible this failure may be related to donor specific blood characteristics that may challenge the trima leukoreduction system, including, but not limited to higher than average donor pre-mnc and/or pre-wbc counts or the high donor bmi.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLT, PLS, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11087984
• MDR Text Key: 227070322
• Report Number: 1722028-2020-00581
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2020

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: 06/01/2022
• Device Catalogue Number: 80405
• Device Lot Number: 2006113130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 06/09/2021; 06/25/2021
• Supplement Dates FDA Received: 06/25/2021; 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other