MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET + AUTO PAS, PLASMA, AUTO RBC

Catalog Number	82470
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
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.Root cause: a definitive root cause for the observed leuko reduction failure remains undetermined at this time.The analysis of the run data file did not show a conclusive root cause for the higher than expected wbc content in the platelet product reported for this collection.There were no events (alerts, adjustments, changes in pump speed, substate changes, etc.) during the procedure that could have caused wbcs to escape from the lrs chamber.It is possible, though not conclusive that this leukoreduction failure is donor related.The trima accel device has software algorithms that use the rbc detector output to monitor and flag if a potential wbc saturation of the lrs chamber occurred, possibly triggering if wbc cells exiting the lrs chamber and potentially contaminate the platelet product.At all times during the procedure the test were in place, however the level of detection of wbcs escaping from the lrs chamber did not yet trigger one or more of the algorithms.
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 bloodcell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.Donor unit no: (b)(6) the platelet collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL LRS PLATELET + AUTO PAS, PLASMA, AUTO RBC
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8151707
• Report Number: 1722028-2018-00335
• Device Sequence Number: 13847915
• Product Code: GKT
• UDI-Device Identifier: 05020583824706
• UDI-Public: 05020583824706
• Combination Product (Y/N): N
• PMA/510(K) Number: BK170157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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: 04/01/2020
• Device Catalogue Number: 82470
• Device Lot Number: 1804112230
• 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: 11/19/2018
• Initial Report FDA Received Date: 12/11/2018
• 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