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

Model Number	82440
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	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number and expiry information are not available at this time investigation : per the customer, the case was reviewed with their medical team and they have determined that there does not appear to be a significant donor-related issues based on the cbc numbers.The run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was possibly a result of an escape of wbc from the lrs chamber near the end of the platelet collection.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 due to elevated %mono on the donor cbc for his wbc differential.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 white blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.Donor unit #: (b)(6).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.4, h.6 and h.10 and corrected information in d.2 and d.4.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow up report will be provided.
Additional Manufacturer Narrative
Investigation : the donor pre procedure cbc results were provided to aid in the investigation.The donor cbc confirmed the following: the donor's wbc is 9.16e3/ul.Although it is slightly elevated, it is within the normal range of 10e3/ul.The donor's platelet count is 395e3/ul.Although it is slightly elevated, it is within the normal range.5-part differential confirmed that the % monocyte count is 10.9% which is outside the normal range.Root cause: the signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was possibly a result of an escape of wbc from the lrs chamber near the end of the platelet collection.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 due to the donor's elevated % monocytes, which may have an impact on the lrs chamber holding capacity, hence reaching lrs saturation earlier than the system predict.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA PLATELET+SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10959343
• Report Number: 1722028-2020-00533
• Device Sequence Number: 702437
• Product Code: GKT
• UDI-Device Identifier: 05020583824409
• UDI-Public: 05020583824409
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Followup
• Report Date (Section B): 12/07/2020

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: 08/01/2022
• Device Model Number: 82440
• Device Catalogue Number: 82446
• Device Lot Number: 2008024151
• 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: 11/13/2020
• Supplement Date Received by Manufacturer: 02/05/2021; 02/23/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 02/12/2021; 03/03/2021
• 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