MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT +20ML SAMPLER, MULTIPLS, RBC

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 01/24/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was possibly a result of an escape of wbcs from the lrs chamber near the end of the collection.It cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor-related.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) 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 h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was possibly a result of an escape of wbcs from the lrs chamber near the end of the collection.It cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor-related.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.Root cause: the signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was possibly a result of an escape of wbcs from the lrs chamber near the end of the collection.It cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor-related.

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.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLT +20ML SAMPLER, MULTIPLS, 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: 13559813
• MDR Text Key: 288604625
• Report Number: 1722028-2022-00049
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

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: 12/01/2023
• Device Model Number: 82416
• Device Catalogue Number: 3824162
• Device Lot Number: 2112131232
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 04/12/2022
• Supplement Dates FDA Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2021
• 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