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

Catalog Number 82420

Device Problems Misassembled (1398); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: photographs were submitted in lieu of the disposable set to aid in the investigation.Analysis of the images revealed a used trima loop assembly.The mini pinch clamp on the platelet line is not properly flossed on the tubing.The open end of the clamp is not assembled on the tubing.Because of this, the clamp cannot occlude the tubing.Based on the available evidence in the images provided, the root cause of the reported failure was a manufacturing mis-assembly.Correction: information regarding failures of this type is regularly shared with the relevant manufacturing teams.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 that occured during pas addition.Per the customer, the clamp was not correctly inserted in the set and could not be used as it was.An additional tubing clamp was used in order not to lose the product.Patient information and outcome are not available at this time.The platelet collection is not available for return because it was discarded by the customer.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.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6, h.10 and corrected information in a.1 and e.1.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.Investigation is in process.A follow up report will be provided.

Event Description

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.

Event Description

Updated information from the customer indicates the customer was able to use their own clamp to process the product without any problems, passing their internal qc (i.E.No elevated wbc count was alleged or confirmed by their testing).

Manufacturer Narrative

Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Per the customer, the "product could be processed and released normally.All subsequent examinations such as vitality or microbiology were inconspicuous." a disposable history search confirmed there were no occurrences of a similar issue reported on this lot worldwide.Root cause: the cause of the clamp failure was related to a misassembly, where the assembler neglected to follow the appropriate manufacturing operating procedure of the disposable set during manufacturing.More specifically, the mini pinch clamp was not adequately flossed onto the channel collect line tubing.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET + SAMPLER, PLASMA, RBC + AUTO PAS
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11754142
• MDR Text Key: 252360101
• Report Number: 1722028-2021-00164
• 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,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Catalogue Number: 82420
• Device Lot Number: 2010151230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other