MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL RBC PLT/PLASMA

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	01/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.The run data file was investigated for the procedure on (b)(6) 2022.The operator selected procedure 6, a 7.0e11 platelet yield with 200 ml plasma and 251 ml rbc collection.At 18 minutes, the operator made one ¿return flow down¿ adjustment.There were no alerts or other flow adjustments made by the operator for the remainder of the collection.At the end of the 77-minute procedure, the trima accel system displayed the following messages: ¿platelet product: label as leukoreduced¿ and 'plasma product: label as leukoreduced'.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.Donor unit #: (b)(6) the platelet collection 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 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.Donor unit #: (b)(6) the platelet collection is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.The run data file was investigated for the procedure on (b)(6) 2022.The operator selected procedure 6, a 7.0e11 platelet yield with 200 ml plasma and 251 ml rbc collection.At 18 minutes, the operator made one ¿return flow down¿ adjustment.There were no alerts or other flow adjustments made by the operator for the remainder of the collection.At the end of the 77-minute procedure, the trima accel system displayed the following messages: ¿platelet product: label as leukoreduced¿ and 'plasma product: label as leukoreduced'.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 additional information in h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.The run data file was investigated for the procedure on (b)(6) 2022.The operator selected procedure 6, a 7.0e11 platelet yield with 200 ml plasma and 251 ml rbc collection.At 18 minutes, the operator made one ¿return flow down¿ adjustment.There were no alerts or other flow adjustments made by the operator for the remainder of the collection.At the end of the 77-minute procedure, the trima accel system displayed the following messages: ¿platelet product: label as leukoreduced¿ and 'plasma product: label as leukoreduced'.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: 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.
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.Donor unit #: (b)(6) the platelet collection is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL RBC PLT/PLASMA
• 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: 13507385
• Report Number: 1722028-2022-00043
• Device Sequence Number: 6432045
• 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): 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): 02/10/2022

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: 09/01/2023
• Device Model Number: 80400
• Device Catalogue Number: 80400
• Device Lot Number: 2109071130
• 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: 01/17/2022
• Supplement Date Received by Manufacturer: 06/14/2022; 06/15/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 06/14/2022; 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2021
• 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