MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL RBC PLS AUTORAS

Model Number 80520

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 06/30/2020

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 second unit of the double red cell collection could be due to the flow not going through the filter medium as expected.The centrifuge pressure was lower during the collection of the second unit, and the overall product volume of the second unit is higher than expected.This could be due to a faulty filter, filter misload, or if the filter had been removed from the bracket at any time during collection.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 red blood cell (rbc) 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 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 h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: the signals in the run data file indicate that the higher-than-expected wbc content in the second unit of the double red cell collection could be due to the flow not going through the filter medium as expected.The centrifuge pressure was lower during the collection of the second unit, and the overall product volume of the second unit is higher than expected.This could be due to a faulty filter, filter misload, or if the filter had been removed from the bracket at any time during collection.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL RBC PLS AUTORAS
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10338312
• MDR Text Key: 202212436
• Report Number: 1722028-2020-00354
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583805200
• UDI-Public: 05020583805200
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Model Number: 80520
• Device Catalogue Number: 80520
• Device Lot Number: 2005212230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other