MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET + 35 ML SAMPLER, MULTIPLASMA, RBC SET

Model Number 82416

Device Problems Contamination of Device Ingredient or Reagent (2901); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/29/2021

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.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.Donor unit #: (b)(6) customer emailed requesting a procedural investigation for an unflagged wbc contamination.The platelet collection is not available for return because it was discarded by the customer.

Event Description

The customer reported during setup, the operator heard noise from the return pump header and found air flowed into the diversion bag.No patient (donor) was connected at the time of the event, therefore, no patient information is available.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.Donor unit #:(b)(6), the platelet collection is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in a.1, b.3, b.5, b.6, d.5, d.8, h.6 and h.10.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.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET + 35 ML SAMPLER, MULTIPLASMA, RBC 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: 12863460
• MDR Text Key: 286664162
• Report Number: 1722028-2021-00363
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824164
• UDI-Public: 05020583824164
• 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,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 82416
• Device Catalogue Number: 3824162
• Device Lot Number: 2109082232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2021
• 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