MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT + SAMPLER, PLASMA, AUTOR

Catalog Number 4826162

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

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

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file was analyzed for this event.The signals in the run data file indicate that the higher-than-expected wbc content in the platelet product reported for this collection was possibly the result of a wbc saturation of the lrs chamber throughout the procedure.Based on the available information, it cannot be ruled out that a potential air block or plasma line occlusion within the centrifuge may have contributed to the observed signal.Additionally, it also cannot be ruled out that the higher-than-expected wbc content in the platelet product may have been donor-related.Investigation is in progress and 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) 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) 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 was analyzed for this event.The signals in the run data file indicate that the higher-than-expected wbc content in the platelet product reported for this collection was possibly the result of a wbc saturation of the lrs chamber throughout the procedure.Based on the available information, it cannot be ruled out that a potential air block or plasma line occlusion within the centrifuge may have contributed to the observed signal.Additionally, it also cannot be ruled out that the higher-than-expected wbc content in the platelet product may have been donor-related.It has been determined that the event submitted on this report is a duplicate of the event submitted on report 1722028-2023-00420.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLT + SAMPLER, PLASMA, AUTOR
• 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: 18857734
• MDR Text Key: 337126505
• Report Number: 1722028-2024-00073
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 35020583826169
• UDI-Public: 35020583826169
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

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: 4826162
• Device Lot Number: 2306161142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2023
• 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