MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLATELET + SAMPLER AUTO PAS, MULTIPLASMA

Model Number	460
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.The analysis of the run data file did not find a conclusive cause for the higher-than-expected wbc content in the platelet product reported for this collection.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.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 #: (b)(6).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: 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.
Additional Manufacturer Narrative
This report is being filed to provide root cause: the analysis of the run data file did not find a conclusive cause for the higher-than- expected wbc content in the platelet product reported for this collection.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.Regarding the high yield of the platelet product, a definitive root cause could not be determined.Possible causes include but are not limited to: ¿ entry of incorrect donor characteristics including pre platelet count, hematocrit, height and weight.Incorrectly configured machine variables (i.E.Target yield not accurate, inaccurate yield scaling factor).Sampling aliquot contains platelet aggregates which could lead to a higher platelet count once the aggregates are dispersed.¿ improper resting and mixing of platelet product prior to sampling.Improper sampling technique and dilution.Inaccurate yield scaling factor.Use of a scale or cell counter that is not calibrated.Use of improper tare weight and/or specific gravity to calculate product volume.Variability of supplied parts or misassembly in the set.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL PLATELET + SAMPLER AUTO PAS, MULTIPLASMA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11405443
• Report Number: 1722028-2021-00089
• Device Sequence Number: 19984086
• Product Code: GKT
• UDI-Device Identifier: 20613031824602
• UDI-Public: 20613031824602
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 03/03/2021

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: 10/01/2022
• Device Model Number: 460
• Device Catalogue Number: 82460
• Device Lot Number: 2010161130
• 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: 02/10/2021
• Supplement Date Received by Manufacturer: 06/04/2021; 08/06/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 06/23/2021; 08/26/2021
• 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