MAUDE Adverse Event Report: TRIMA ACCEL TRIMA ACCEL; TRIMA ACCEL LRS PLATELET, PLASMA SET

Model Number	82300
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	04/13/2023
Type of Reportable Event	Malfunction
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 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
Investigation: a terumo bct service technician checked out the machine at the customer site.The technician performed a device check and checked the electrical connection.Cleaning was performed and an auto test was completed successfully.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 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 b.6 and h.10.Corrected information is provided in b.3.Investigation: a terumo bct service technician checked out the machine at the customer site.The technician performed a device check and checked the electrical connection.Cleaning was performed and an auto test was completed successfully.The run data file (rdf) was analyzed for this event.The procedure flagged for possible wbc contamination, as during the procedure, the hct of the donor was increased 6 percent-points.In this case, the leukoreduction of the platelet product cannot be guaranteed and the platelet product will be flagged for possible wbc contamination.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 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 b.6 and h.10.Investigation: a terumo bct service technician checked out the machine at the customer site.The technician performed a device check and checked the electrical connection.Cleaning was performed and an auto test was completed successfully.The run data file (rdf) was analyzed for this event.The procedure flagged for possible wbc contamination, as during the procedure, the hct of the donor was increased 6 percent-points.In this case, the leukoreduction of the platelet product cannot be guaranteed and the platelet product will be flagged for possible wbc contamination.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 procedure flagged for possible wbc contamination, as during the procedure, the hct of the donor was increased 6 percent-points.In this case, the leukoreduction of the platelet product cannot be guaranteed and the platelet product will be flagged for possible wbc contamination.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL LRS PLATELET, PLASMA SET
• Manufacturer (Section D): TRIMA ACCEL; 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: 16912856
• Report Number: 1722028-2023-00178
• Device Sequence Number: 17731586
• Product Code: GKT
• UDI-Device Identifier: 05020583823006
• UDI-Public: 05020583823006
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2023

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: 11/01/2024
• Device Model Number: 82300
• Device Catalogue Number: 82300
• Device Lot Number: 2211254151
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 08/09/2023; 08/22/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 08/14/2023; 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2022
• 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