MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLT AUTO PAS PLASMA RBC SET

Catalog Number	80410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf showed that alerts that are known to contribute to wbc contamination were not generated in this run data file.As the trima system cannot count the cells entering the platelet product bag, the rbc detector signals must see a significant change in the reflectance values to notify the operator ofan lrs chamber saturation and to count the wbcs in the platelet product.In this case, the signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data file reported that the platelet product could be labeled as leukoreduced.Although the trima system has several methods for detection of possible wbc contamination, it is possible that some events may elude the detection capability of the trima system.Run data file analysis did not show a conclusive root cause for the elevated wbc content in the platelet product reported for this collection.Based on the available information, it is possible,though not conclusive, this failure may be related to donor specific blood characteristics that may challenge the trima leukoreduction system.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 wbc count is not available at this time.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 corrected.
Additional Manufacturer Narrative
This report is being filed to provide in corrected information is being provided in e.1.Investigation: further evaluation of this event has determined that the device did notcause or contribute to a death or serious injury, nor is there a likely potential for death or seriousinjury associated with this event based on additional investigational information.During customerfollow- up, it was confirmed that the wbc count was below <5x10^6.The device history records (dhr) were reviewed for this lot.There were no events noted inthe 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 unusualprocess variable was identified and the signals in the run data file indicate that the trima accelsystem operated as intended.Based on the available information, it cannot be ruled out that thehigher- than-expected wbc content in the platelet product could be donor-related.Alerts that are known to contribute to wbc contamination were not generated in this rundata file.As the trima system cannot count the cells entering the platelet product bag, the rbcdetector signals must see a significant change in the reflectance values to notify the operatorof an lrs chamber saturation and to count the wbcs in the platelet product.In this case, thesignals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data filereported that the platelet product could be labeled as leukoreduced.Although the trimasystem has several methods for detection of possible wbc contamination, it is possible that someevents may elude the detection capability of the trima system.Run data file analysis did not showa conclusive root cause for the elevated wbc content in the platelet product reported for thiscollection.Based on the available information, it is possible, though not conclusive, this failuremay be related to donor specific blood characteristics that may challenge the trima leukoreductionsystem.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL LRS PLT AUTO PAS PLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8452227
• Report Number: 1722028-2019-00066
• Device Sequence Number: 19537706
• Product Code: GKT
• UDI-Device Identifier: 05020583804104
• UDI-Public: 05020583804104
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: BK170059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/26/2019

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: 11/01/2019
• Device Catalogue Number: 80410
• Device Lot Number: 1711291130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 04/09/2019; 04/09/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 04/12/2019; 04/12/2019
• 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