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

Catalog Number 82310

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2017

Event Type  malfunction  

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.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.Wbc count is not available at this time.Terumo bct is awaiting return of the platelet collection set for evaluation.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.Investigation: the trima disposable set was returned for investigation.Upon visual inspection, it was confirmed the set was assembled correctly with no leaks, kinks, occlusions or missing parts.Flow of blood was verified throughout the cassette, channel, inlet and return lines.There was no evidence of clumping in the channel connector.Pas solution was attached and all channel line pinch clamps were observed closed.No disposable defects were identified.Root cause: a definitive root cause for the observed leukoreduction failure remains undetermined at this time.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: the run data file (rdf) was analyzed for this event.Updated root cause: nothing prominent was observed in the run data file that explains the higher than expected wbc content in the platelet product reported for this collection.There were no events (alerts, adjustments, changes in pump speed, substate changes, etc.) during the procedure that could have caused wbcs to escape from the lrs chamber.It is possible, though not conclusive, that wbcs may have exited the lrs chamber throughout the procedure.Based on the available information, it is possible, that this leukoreduction failure is donor related.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET,SAMPLER, AUTOPAS, MULTIPLASMA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w.collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6773478
• MDR Text Key: 83118333
• Report Number: 1722028-2017-00318
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: K162365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2017

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: 04/01/2019
• Device Catalogue Number: 82310
• Device Lot Number: 1704121231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2017
• Initial Date FDA Received: 08/08/2017
• Supplement Dates Manufacturer Received: 08/17/2017; 09/19/2017
• Supplement Dates FDA Received: 08/29/2017; 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other