MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL RBC PLS AUTORAS

Model Number	80520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the higher-than-expected wbc content in the second unit of the double red cell collection could be due to the flow not going through the filter medium as expected.The centrifuge pressure was lower during the collection of the second unit, and the overall product volume of the second unit is higher than expected.This could be due to a faulty filter, filter misload, or if the filter had been removed from the bracket at any time during collection.Investigation is in process.A follow-up report will be provided.
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.Donor unit #: (b)(6).The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: the signals in the run data file indicate that the higher-than-expected wbc content in the second unit of the double red cell collection could be due to the flow not going through the filter medium as expected.The centrifuge pressure was lower during the collection of the second unit, and the overall product volume of the second unit is higher than expected.This could be due to a faulty filter, filter misload, or if the filter had been removed from the bracket at any time during collection.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL RBC PLS AUTORAS
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10338312
• Report Number: 1722028-2020-00354
• Device Sequence Number: 19301540
• Product Code: GKT
• UDI-Device Identifier: 05020583805200
• UDI-Public: 05020583805200
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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: 80520
• Device Catalogue Number: 80520
• Device Lot Number: 2005212230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 02/05/2021
• 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