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

Model Number	82470
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional 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.The run data file (rdf) was analyzed for this event.The customer returned the rbc bag and filter from a used trima set for investigation.Visual inspection confirmed the returned components were assembled correctly with no manufacturing defects identified.There was no damage to the filter housing.Both the filter and collection bag were saturated with rbcs.Root cause: a definitive root cause for the higher than expected wbc content in the rbc products reported for this collection remains undetermined at this time.The analysis of the run data file did not show any events during the procedure that could have caused the leukoreduction failure.The centrifuge pressure graph during the rbc product collection looked completely normal, as did the rbc additive solution pressures.Potential causes for the leukoreduction failure include, but are not limited to: - improper loading of the filter into the filter bracket - removing the filter from the bracket or adjusting the filter position once rbc collection started - a manufacturing defect of the filter.
Event or Problem 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 red blood cell (rbc) 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.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL LRS PLATELET AUTO PAS,PLASMA, AUTO RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10684470
• Report Number: 1722028-2020-00475
• Device Sequence Number: 14193647
• Product Code: GKT
• UDI-Device Identifier: 05020583824706
• UDI-Public: 05020583824706
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/15/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2022
• Device Model Number: 82470
• Device Catalogue Number: 82470
• Device Lot Number: 2005072130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other