MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT SMPLR AUTOPAS, MULTI PLS, RBC

Catalog Number 4824602

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 03/20/2024

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 elevated white blood cell (wbc) content in the platelet product.Donor unit (b)(6) the wbc count is not available, the unit was not sent for rwbc testing.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.

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.Donor unit #: (b)(4) the wbc count is not available, the unit was not sent for rwbc testing.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.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the pumped volumes were all within the expected ranges, and that all checks were passed during additive solution addition.Based on the available information, it cannot be ruled out that the clamp which was left partially open may have resulted in rbcs being pulled from the channel and into the platelet product bags.Additionally, it cannot be ruled out that the cassette may not have been completely cleaned of rbcs prior to the platelet valve opening to add pas to the product bags.The signals in the run data file indicate that the green reflectance value dropped to just above the threshold needed in order to flag the platelet product for wbc verification during pas addition.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.Donor unit #: (b)(6) the wbc count is not available, the unit was not sent for rwbc testing.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.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.11.Investigation: the run data file (rdf) was analyzed for this event.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.Photographs were submitted in lieu of the disposable set to aid in the investigation.Analysis of the images revealed the platelet product bag of a trima disposable set.The product is confirmed to have a strong red tinge which confirms the reported spillover.Root cause: the signals in the run data file indicate that the pumped volumes were all within the expected ranges, and that all checks were passed during additive solution addition.Based on the available information, it cannot be ruled out that the clamp which was left partially open may have resulted in rbcs being pulled from the channel and into the platelet product bags.Additionally, it cannot be ruled out that the cassette may not have been completely cleaned of rbcs prior to the platelet valve opening to add pas to the product bags.The signals in the run data file indicate that the green reflectance value dropped to just above the threshold needed in order to flag the platelet product for wbc verification during pas addition.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLT SMPLR AUTOPAS, MULTI PLS, RBC
• 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: 19098531
• MDR Text Key: 340109550
• Report Number: 1722028-2024-00142
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK190332
• 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: 04/12/2024

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: 4824602
• Device Lot Number: 2304252142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/15/2024; Not provided
• Supplement Dates FDA Received: 05/07/2024; 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2023
• 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