MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET SAMPLER,AUTOPAS,PLASMA,RBCSET

Catalog Number 82420

Device Problems Incorrect Or Inadequate Test Results (2456); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Run data file analysis did not show a conclusive root cause for the higher than expected wbc content in the platelet product reported for this collection.However, it is possible, though not conclusive, wbcs may have escaped the lrs chamber late in the procedure.As this may have only occurred for a short time, the wbc contamination detection algorithms were unable to flag this failure before the collection completed.Based on the available information, it is possible though not conclusive, this failure maybe donor related.The measured platelet product concentration or yield was not provided.However, historically this site has experienced collections with measured platelet product yields about 20% greater than the targeted platelet yield on average.When greater than 100% of the targeted platelet yield is achieved, a higher platelet concentration than configured is also achieved.The target platelet concentration for this site is 3500 plts/l before platelet additive solution (pas) addition; therefore, when 20% more is collected, a concentration of about 4200 plts/l is achieved.If the platelet concentration is configured greater than 4200 plts/l, the trima will automatically flag for the ¿platelet concentration too high¿ wbc verification reason.Thus, when the platelet concentration approaches 4200 plts/l before pas addition, wbc contamination risks are increased.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.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.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.Root cause: the run data file analysis did not show a conclusive root cause for the higher than expected wbc content in the platelet product reported for this collection.However, it is possible, though not conclusive, wbcs may have escaped the lrs chamber late in the procedure.As this may have only occurred for a short time, the wbc contamination detection algorithms were unable to flag this failure before the collection completed.Based on the available information, it is possible though not conclusive, this failure may be donor related.The targeted platelet product yield was a 9.0e11 and the measured platelet product yield was an 11.6e11.Historically this site has experienced collections with measured platelet product yields about 20% greater than the targeted platelet yield on average.When greater than 100% of the targeted platelet yield is achieved, a higher platelet concentration than configured is also achieved.The target platelet concentration for this site is 3500 plts/l before platelet additive solution (pas) addition; and in this case, when 29% more is collected, a concentration of about 4515 plts/l is achieved.If the platelet concentration is configured greater than 4200 plts/l, the trima will automatically flag for the ¿platelet concentration too high¿ wbc verification reason.Thus, when the platelet concentration approaches or exceeds 4200 plts/l before pas addition, wbc contamination risks are increased.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET SAMPLER,AUTOPAS,PLASMA,RBCSET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7561445
• MDR Text Key: 110458726
• Report Number: 1722028-2018-00156
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Catalogue Number: 82420
• Device Lot Number: 1709141130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 06/18/2018
• Supplement Dates FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2017
• 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