MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET SAMPLER AUTOPAS, MULTIPLASMA

Catalog Number 82310

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); No Apparent Adverse Event (3189)

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

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.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 overflow into the platelet concentrate when the additive solution was added.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.The platelet collection set 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.The wbc count is not available, at this time.

Manufacturer Narrative

This report is being filed to provide additional information in b.6 and h.10 investigation : the run data file (rdf) was analyzed for this event.Run data file analysis confirmed a platelet product yield and volume verification message was displayed prior to pas addition but no verification message was listed at the end of run summary screens after pas had been added to the platelet product bags.The reason given for the platelet product yield and volume verification message shown prior to pas addition was: "predicted plasma carryover may be out of range".This verification reason was shown because at that time, the system was erroneously still predicting the required pas volume for the original higher platelet volume procedure selection, rather than the lower pas volume necessary for the last selected lower platelet volume procedure.After the operator continued from the pre-pas verification screen and entered the pas addition stages, the system corrected this mistake and the proper pas volume was added to the platelet product bags.Therefore, no post-pas end of run verification message was required.Analysis identified this issue to be a software anomaly.As such, the issue has been elevated to the software team.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.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.The customer confirmed there was no indication or accusation of rwbc contamination.This was confirmed by the dlog analysis.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in e.1, e.3, h.6 and h.10.Investigation: dhr not required as the dlog indicated the reported issue was related to a software anomaly.Root cause: run data file analysis confirmed a platelet product yield and volume verification message was displayed prior to pas addition but no verification message was listed at the end of run summary screens after pas had been added to the platelet product bags.The reason given for the platelet product yield and volume verification message shown prior to pas addition was: "predicted plasma carryover may be out of range".This verification reason was shown because at that time, the system was erroneously still predicting the required pas volume for the original higher platelet volume procedure selection, rather than the lower pas volume necessary for the last selected lower platelet volume procedure.After the operator continued from the pre-pas verification screen and entered the pas addition stages, the system corrected this mistake and the proper pas volume was added to the platelet product bags.Therefore, no post- pas end of run verification message was required.Analysis identified this issue to be a software anomaly.As such, the issue has been elevated to the software team.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET SAMPLER AUTOPAS, MULTIPLASMA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11078283
• MDR Text Key: 224762007
• Report Number: 1722028-2020-00578
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/28/2020

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 Catalogue Number: 82310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 02/15/2021; 05/07/2021; 05/13/2021
• Supplement Dates FDA Received: 03/04/2021; 05/10/2021; 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other