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

Catalog Number 80440

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event 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.Wbc count is not available at this time.The platelet collection is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.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.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.The run data file (rdf) was analyzed for thisevent.Signals in the rdf confirmed that the trima machine operated as intended by flagging the procedure to verify white blood cells.Root cause: review of the run data file (rdf) showed that during initial blood priming of the kit,at 5 minutes into the run there were cells going by the rbc detector unexpectedly causing a¿prime spillover¿ event.Prime spillover events typically occur when the separation of the cells is not sufficient when priming the channel, leading to a higher rbc interface in the channel.Primes pillovers are more likely to occur if the donor hematocrit is high or entered inaccurately.Another factor that can contribute to these events is improper loading of the disposable kit in the centrifuge.It is also possible that a manufacturing defect with the disposable kit contributed to the event.

Manufacturer Narrative

Further evaluation of this event has determined that the devicedid not cause or contribute to a death or serious injury, nor is there a likely potential for death orserious injury associated with this event based on additional investigational information.The rundata file (rdf) was analyzed for this event.Signals in the rdf confirmed that the trima machineoperated as intended by flagging the procedure to verify white blood cells.During customerfollow- up, it was also confirmed that the wbc count was below <5x10^6.

Manufacturer Narrative

This report is being filed to provide additional information.

Manufacturer Narrative

This report is being filed to provide additional information.Updated root cause: review of the run data file (rdf) showed that during initial blood priming of the kit, at 5 minutes into the run there were cells going by the rbc detector unexpectedly causing a ¿prime spillover¿ event.Prime spillover events typically occur when the separation of the cells is not sufficient when priming the channel, leading to a higher rbc interface in the channel.Analysis of the run data files 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 significant events (alerts, adjustments, changes in pump speed, substate changes, etc.) during the procedure that could have caused wbcs to escape from the lrs chamber.Experience has shown that lower level wbc contaminations may not show conclusive signals in the run data file.Possible causes:- prime spillovers are more likely to occur if the donor hematocrit is high or entered inaccurately.Another factor that can contribute to these events is improper loading of the disposable kit in the centrifuge.- based on the available information, it is possible that this leukoreduction failure may be donor related.- it is also possible that a manufacturing defect with the disposable kit contributed to the event.

Manufacturer Narrative

Updated root cause: 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 significant events (alerts, adjustments, changes in pump speed, substate changes, etc.) during the procedure that could have caused wbcs to escape from the lrs chamber.Experience has shown that lower level wbc contaminations may not show conclusive signals in the run data file.Based on the available information, it is possible that this leukoreduction failure may be donor related.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w.collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6998086
• MDR Text Key: 92211954
• Report Number: 1722028-2017-00429
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: BK160116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/02/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Catalogue Number: 80440
• Device Lot Number: 1704072131
• Other Device ID Number: 05020583804401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 11/02/2017
• Supplement Dates Manufacturer Received: 11/07/2017; 11/29/2017; 01/04/2018; 02/23/2018; 03/09/2018
• Supplement Dates FDA Received: 11/22/2017; 12/15/2017; 01/08/2018; 02/23/2018; 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other