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

Model Number 82440

Device Problems Device Ingredient or Reagent Problem (2910); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2020

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 white blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.Donor unit #: (b)(6).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 h6 and h10.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.The trima accel procedure summary (taps) report was submitted to aid in the investigation.The report confirms there were no flags indicating that the platelet product should be verified for white blood cell contamination.The donor pre platelet count was entered as 545.This donor had an actual precount of 611 on the day of donation.Trima is validated up to donor precount of 575 with maximum entry of 600.Root cause: based on the clinical findings, the cause of the white cell contamination is due to the donor platelet precount being above trima's limit.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLATELET SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10507851
• MDR Text Key: 206188766
• Report Number: 1722028-2020-00429
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824409
• UDI-Public: 05020583824409
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

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: 03/01/2022
• Device Model Number: 82440
• Device Catalogue Number: 82440
• Device Lot Number: 2003184151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other