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

Model Number	80400
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	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number and expiry information are not available at this time.Investigation is in process.A followup 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)(4) 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 b.6, d.4,h.4,h.6,h.11 and corrected information in d.2 and d.4.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.Evaluation of the corresponding taps report indicated trima 1t03750 was loaded with an 80400 tubing set and passed the tubing set test.Selected procedure: 4.0 e11/286 ml platelet product and a 225 ml plasma product with a target procedure time of 31 minutes.There were three ¿draw pressure too low¿ alerts generated between 23 and 31 minutes into the procedure.No other alerts or adjustments occurred during the procedure.The procedure completed with rinseback at 34 minutes.The end of run summary reported 4.0 e11/286 ml platelet product and a 225 ml plasma product.Both the platelet and plasma products could be labeled as leukoreduced with no product verification messages shown.While investigating the rdf, it was noted the predicted volume from trima was 290, which is 16% lower than the reported measured volume for this platelet unit of 339 ml.The evaluator didn't observe anything in the dlog to explain this volume discrepancy or the elevated wbc content.The donor does have a high precount and this is not an lrs saturation level contamination.Trima v7 does have the draw flow leukoreduction feature that helps minimize these lower level contaminations for high precount donors.Root cause: for the rwbc failure: although the system has several methods for detection of wbc contaminations, some events may elude the detection capability of the trima accel system.The following events can occur during the procedure and may contribute to elevated wbc content in the platelet product that the system cannot always detect.A majority of the time, these events will not contribute to elevated wbc content: ¿ multiple alerts or flow adjustments that stop/slow the pumps, disrupting the steady-state collection process ¿ large discrepancy in entered versus actual donor information ¿ plasma line occlusion or air block that was not large enough to be detected by the system ¿ if the configured platelet concentration during collection is above approximately 3500e3/ul, it is possible that an inaccurate platelet yield scaling factor (ysf) configuration can cause the platelet concentration to exceed the lrs chamber holding capacity due to collecting a higher than expected platelet yield additionally, it is possible that the cause is related to donor specific blood characteristics that may challenge the trima leukoreduction system, including, but not limited to: a higher donor bmi, a donor pre-wbc count that is above the trima accel system expectation, larger than average donor platelet size, and/or smaller than average donor wbc or rbc size.For the platelet volume discrepancy: a definitive root cause could not be determined.Possible causes include but are not limited to: ¿ entry of incorrect donor characteristics including platelet precount, hematocrit, height and weight.¿ incorrectly configured machine variables (i.E.Target volume not accurate, inaccurate yield scaling factor).¿ excessive pressure alerts regarding donor venous access issues.¿ numerous adjustments to flow rates or other procedural inputs/parameters during the procedure.¿ failure to follow screen prompts to clamp off platelet bag when collecting double or triple product.¿ use of improper tare weight and/or specific gravity to calculate product volume.¿ use of a scale or cell counter that is not calibrated.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA PLATELET+SAMPLER PLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11056886
• Report Number: 1722028-2020-00563
• Device Sequence Number: 2788673
• Product Code: GKT
• UDI-Device Identifier: 05020583804005
• UDI-Public: 05020583804005
• 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): Y
• 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): 12/22/2020

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: 80400
• Device Catalogue Number: 80440
• Device Lot Number: 2005094151
• 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: 12/02/2020
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 05/28/2021
• 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