MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLATELET SAMPLER, PLASMA, RBC SET

Model Number	82440
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.Per rdf analysis, the point in the collection that wbcs began exiting the lrs chamber, the trima did not give the message to verify the wbc content in this specific run.Trima uses the rbc detector to monitor for changes in the cellular concentration passing by it as a potential indication of contamination.In the case of this procedure, the wbcs began exiting quite early into the collection at the same time that trima was establishing the baseline and calculating what was "normal" concentration to then monitor against for contamination.This prohibited trima from being able to see the contamination.The fact that this contaminating began so early into the collection, much before the first scheduled lrs chamber clearing, suggests the donor may have had an elevated wbc count on the day of this collection.This could be specific to the time of this donation or could also be a donor-related phenomenon for this particular donor.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 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.Donor unit #:w037920116118 the platelet 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.Investigation is in process.A follow up report will be provided.
Additional Manufacturer Narrative
Root cause: the contamination of wbcs in the platelet product was likely caused by an air block or occlusion in the disposable set.The cause of the air block or occlusion could not be determined.Possible causes include but are not limited to: - misload of the centrifuge components - an occlusion in the disposable set, including solvent or molding occlusions - introduction of air into the anti-coagulant (ac) or inlet line during or after disposable prime.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA PLATELET SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9944078
• Report Number: 1722028-2020-00158
• Device Sequence Number: 16780772
• Product Code: GKT
• UDI-Device Identifier: 05020583824409
• UDI-Public: 05020583824409
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: BK190333
• 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,Followup
• Report Date (Section B): 04/09/2020

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: 11/01/2021
• Device Model Number: 82440
• Device Catalogue Number: 82440
• Device Lot Number: 1911154151
• 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: 03/19/2020
• Supplement Date Received by Manufacturer: 10/22/2020; 10/27/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 10/23/2020; 11/17/2020
• 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