MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLT SAMPLER AUTOPAS PLASMA RBC SET

Catalog Number	80360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/12/2019
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 and did not find a conclusive cause for the higher-than-expected wbc content in the platelet product reported for this collection.There were 14 draw pressure low alerts and 3 adjustments to the inlet flow.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.Based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor-related.Root cause: a conclusive root cause for the higher than expected wbc content in the platelet product reported for this procedure cannot be confirmed through run data file analysis.While the trima accel system is typically robust against numerous autoflow adjustments from access pressure pauses, it cannot be ruled out that the changes in inlet flow rate, and therefore centrifuge speed and lrs chamber flow rate, disrupted the steady state of the system and contributed to the higher than expected wbc content reported for this procedure.It is also possible, though not conclusive, that this leukoreduction failure may be donor related.A potential reason for this donor related leukoreduction failure may be, but is not limited to, a high wbc count.
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 bloodcell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.Donor unit #: (b)(6).The platelet collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL LRS PLT SAMPLER AUTOPAS PLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8312351
• Report Number: 1722028-2019-00030
• Device Sequence Number: 16653032
• Product Code: GKT
• UDI-Device Identifier: 05020583803602
• UDI-Public: 05020583803602
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: BK180231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2019

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: 10/01/2020
• Device Catalogue Number: 80360
• Device Lot Number: 1810312230
• 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: 01/17/2019
• Initial Report FDA Received Date: 02/06/2019
• 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