MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT, AUTOPAS, PLS, AUTORBC SET

Catalog Number	4824702
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
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 show a conclusive root cause for the higher-than-expected wbc content in the rbc products reported for this collection.There were no events during the procedure that could have caused the leukoreduction failure.The centrifuge pressure graph during the rbc product collection looked completely normal, as did the rbc additive solution pressures.Potential causes for the leukoreduction failure include, but are not limited to: improper loading of the filter into the filter bracket removing the filter from the bracket or adjusting the filter position once rbc collection started a manufacturing defect of the filter 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.After a second filtration the product was controlled again and the result of wbcs was 0.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.The platelet collection set is not available for return because it was discarded by the customer.
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.After a second filtration the product was controlled again and the result of wbcs was 0.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.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 run data file (rdf) was analyzed for this event: the analysis of the run data file did not show a conclusive root cause for the higher-than-expected wbc content in the rbc products reported for this collection.There were no events during the procedure that could have caused the leukoreduction failure.The centrifuge pressure graph during the rbc product collection looked completely normal, as did the rbc additive solution pressures.Potential causes for the leukoreduction failure include, but are not limited to: improper loading of the filter into the filter bracket removing the filter from the bracket or adjusting the filter position once rbc collection started a manufacturing defect of the filter 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
Investigation: the run data file (rdf) was analyzed for this event: the analysis of the run data file did not show a conclusive root cause for the higher-than-expected wbc content in the rbc products reported for this collection.There were no events during the procedure that could have caused the leukoreduction failure.The centrifuge pressure graph during the rbc product collection looked completely normal, as did the rbc additive solution pressures.Potential causes for the leukoreduction failure include, but are not limited to: improper loading of the filter into the filter bracket removing the filter from the bracket or adjusting the filter position once rbc collection started a manufacturing defect of the filter 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.Root cause: a root cause assessment was performed for this complaint.The analysis of the run data file did not show a conclusive root cause for the higher-than-expected wbc content in the rbc products reported for this collection.There were no events during the procedure that could have caused the leukoreduction failure.The centrifuge pressure graph during the rbc product collection looked completely normal, as did the rbc additive solution pressures.Potential causes for the leukoreduction failure include, but are not limited to: improper loading of the filter into the filter bracket removing the filter from the bracket or adjusting the filter position once rbc collection started a manufacturing defect of the filter.
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.After a second filtration the product was controlled again and the result of wbcs was 0.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.The platelet collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA PLT, AUTOPAS, PLS, AUTORBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 18651002
• Report Number: 1722028-2024-00041
• Device Sequence Number: 20629711
• Product Code: GKT
• UDI-Device Identifier: 05020583824706
• UDI-Public: 05020583824706
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2024

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 Catalogue Number: 4824702
• Device Lot Number: 2305171142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 02/12/2024; 03/04/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 02/29/2024; 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown