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

Model Number 82446

Device Problems Partial Blockage (1065); High Test Results (2457)

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

Event Date 11/16/2020

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

Root cause :based on the findings from the run data file analysis, the leukodreduction failure was caused by an air block in the plasma line.The airblock likely occurred when the centrifuge was stopped during blood prime.The excess plasma flow destabilized the cell bed in the lrs chamber causing some wbcs to escape from the chamber.

Manufacturer Narrative

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 run data file (rdf) was analyzed for this event.Analysis of the run data file determined there was an airblock in the plasma line for the entire collection, likely introduced when the centrifuge was stopped during blood prime.Having the plasma line blocked caused more fluid to be drawn through the lrs chamber since we were missing the plasma pump contribution.And since the procedure looked the same for the whole collection, there wasn't a change in signal to the rbc detector to induce the flag.Investigation is in process.A follow up report will be provided.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLATELET+SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11003426
• MDR Text Key: 222289914
• Report Number: 1722028-2020-00546
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824461
• UDI-Public: 05020583824461
• 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,Followup
• Report Date: 12/14/2020

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: 08/01/2022
• Device Model Number: 82446
• Device Catalogue Number: 82446
• Device Lot Number: 2008034151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 01/29/2021; 02/23/2021
• Supplement Dates FDA Received: 02/18/2021; 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other