MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLASMA SET

Catalog Number 80537

Device Problems Contamination /Decontamination Problem (2895); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: the disposables set was returned to terumo bct (b)(4) for evaluation.Terumo bct (b)(4) has confirmed the customer¿s statement and found the following: the possible root cause was unknown.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a collection procedure on the trima machine, the operator noticed that there was blood in the plasma bag and the color was red.Patient information and outcome are not available at this time.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 corrected in investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide in investigation:a review of the device history record (dhr) for this unit showed no irregularitiesduring manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.However, it is difficult to see any signals forwhat is exiting the plasma line for the reported type of set.The plasma line does not bypassthe rbc detector, so there is no way for the system to monitor for a spillover.Root cause: run data file analysis did not show a conclusive root cause for the red blood in theplasma bag reported for this collection.All signals in the run data file appeared as expected withno indications of red blood entering the plasma bag.It is possible, though not conclusive, the redblood in the plasma bag may have been caused by:¿ an inaccurately entered donor hematocrit¿ a donor related phenomenon¿ a loading error of the tubing set¿ a potential disposable set defect.

Event Description

Due to japanese privacy laws, the customer was unable to provide information of patientidentifier and age or outcome.Patient's gender and weight information were obtained from therun data files (rdf).No medical intervention was reported to tbct for this event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8678408
• MDR Text Key: 147596881
• Report Number: 1722028-2019-00133
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: 80537
• Device Lot Number: 1810315251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 06/20/2019; 07/09/2019
• Supplement Dates FDA Received: 07/02/2019; 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 67