MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET, SAMPLER, AUTO PAS, MULTIPLAS

Catalog Number 82310

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 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number and manufacture dates are not available at this time.Investigation: the run data file (rdf) was analyzed for this event.Run data file analysis did not show a conclusive root cause for the higher than expected wbc content measured in the platelet product reported for this collection.Based on the available information, it is possible though not conclusive, this failure may be donor related.This report was filed beyond the 30-day timeframe due to an internal processing error.An internal capa has been initiated to address the issue.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 unit processing, therefore no patient information is reasonably known at the time of the event.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.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 in investigation: the lot number was unavailable per the customer.The customer did notprovide the lot number pertaining to this event, therefore a device history record (dhr) searchcould not be conducted for this specific incident.All lots must meet acceptance criteria beforerelease.Root cause: a definitive root cause for the observed leukoreduction failure remainsundetermined at this time.Run data file analysis did not show a conclusive root cause for the higher than expected wbccontent measured in the platelet product reported for this collection.Based on the availableinformation, it is possible though not conclusive, this failure may be donor related.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, SAMPLER, AUTO PAS, MULTIPLAS
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8647060
• MDR Text Key: 147240056
• Report Number: 1722028-2019-00125
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other