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

Model Number	82440
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Donor unit id: (b)(6) 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 platelet product.Donor unit id: (b)(6) 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: 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 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.The run data file (rdf) was analyzed for this event.The relevant rdf was investigated and the following was noted: ¿ precount inaccuracy: entered value was 384 and actual venous precount was 459.Not a huge discrepancy but at 15% difference there is a chance for overcrowding of the lrs chamber with more platelets being in the system than expected.¿ high precount: we made enhancements with trima v7 to better manage the lrs chamber contents during the establishment of the platelet bed at the beginning of the procedure for donors with high precounts.Root cause: likely this low level contamination occurred at the beginning of the collection when the lrs chamber was being set up.Version 7 would help with this as well as having accurate precount for this donor with such a high precount.
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.Donor unit id: (b)(6) 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 PLATELET SAMPLER, PLASMA, RBC 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: 12408393
• Report Number: 1722028-2021-00290
• Device Sequence Number: 16445771
• Product Code: GKT
• UDI-Device Identifier: 05020583824409
• UDI-Public: 05020583824409
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 09/01/2021

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: 08/01/2022
• Device Model Number: 82440
• Device Catalogue Number: 5824401
• Device Lot Number: 2008044151
• 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: 08/10/2021
• Supplement Date Received by Manufacturer: 11/09/2021; 12/07/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 11/12/2021; 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2020
• 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