MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; ACCEL PLATELET PLASMA SET

Catalog Number 80337

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

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2022

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time 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 wbc 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.

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 wbc 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 b.6, e.1, h.6 and h.10.Investigation: the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.The run data file (rdf) was analyzed for this event root cause: a root cause assessment was performed for this complaint.The trima accel lrs chamber holds platelets at the top of the cone due to their smaller size, trapping the larger wbcs in the lower section of the chamber.This provides in-process leukoreduction of the platelet product.The lrs chamber has a maximum holding capacity that mainly depends on the flow rate through the lrs chamber and the donor parameters.A leukoreduction failure of the platelet product can occur when the separation within the lrs chamber has been disrupted or the lrs chamber holding capacity has been exceeded.The trima accel system is continuously monitoring the leukoreduction process using the rbc detector.Alerts that are known to contribute to wbc contamination were not generated in this procedure.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 procedure, 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.Analysis did show this device was used for the most platelet collections and the highest number of pc20 collections (higher collect concentration platelet product) at the center between 31 august and 30 september.Possible machine-specific causes may include, but are not limited to: * variation in filler geometry that could move the buffy coat interface within the channel, leading to an increased number of wbcs in the lrs chamber, more easily exceeding the holding capacity.* off-balance filler that could impact the separation in the channel and /or lrs chamber.* inadequate occlusion at the valves that could lead to cells entering the platelet product bag during rinseback.* inadequate occlusion at the pumps that could lead to higher than expected flow rates through the channel, lrs chamber, and into the platelet product bag during collection.Based on the available information, it is also possible these failures 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/pre-wbc counts, larger than average donor platelet size, smaller than average donor wbc or rbc size, and/or inaccurate precounts entered.

• Brand Name: TRIMA ACCEL
• Type of Device: ACCEL PLATELET PLASMA SET
• 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: 16358350
• MDR Text Key: 309385989
• Report Number: 1722028-2023-00051
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 02/10/2023

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: 80337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 03/06/2023
• Supplement Dates FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: No
• 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