MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT SAMPLER AUTOPAS MULTIPLS SET

Catalog Number 80310

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 12/13/2017

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.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 corrected information.

Event Description

Donor unit #: (b)(6).

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the run data file (rdf) was analyzed for this event.Root cause: a definitive root cause for the observed leukoreduction failure remains undetermined at this time.Nothing prominent was observed in the rdf which explains the higher than expected wbc content in the platelet product reported for this collection.The trima accel device has software algorithms that use the red blood cell (rbc) detector output to monitor and flag if a potential wbc saturation of the leukocyte reduction (lrs) chamber occurred, possibly triggering if wbc cells exiting the lrs chamber and potentially contaminate the platelet product.Analysis of the rbc signal shows that wbcs may have exited the lrs chamber towards the end of the collect procedure, however, the detection level was not high enough to trigger the wbc algorithms.Based on available information, it is possible that this leukoreduction failure is donor related.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLT SAMPLER AUTOPAS MULTIPLS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7186839
• MDR Text Key: 97907891
• Report Number: 1722028-2018-00010
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK150321
• 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: 01/12/2018

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: 11/01/2018
• Device Catalogue Number: 80310
• Device Lot Number: 11Z1123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 02/05/2018; 03/01/2018
• Supplement Dates FDA Received: 02/06/2018; 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2016
• 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