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

Catalog Number 80355

Device Problems Partial Blockage (1065); Coagulation in Device or Device Ingredient (1096); Overfill (2404); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacture date and expiry are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that near the end of the procedure on trima, they received a'spillover' alarm and noticed air bubbles in the collection line and clumping in the collection bag.The operator stopped the procedure.The information for the investigation such as procedural details and patient information and outcome is not available at this time.The trima disposable set 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 a alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed tp provide additional information in e.1 and e.3.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide and correctedinformation in b.3.Investigation: the air reported was on the right side of the cassette which would have beensent to the reservoir and migrate to the vent bag, not to the patient.Air was not observed pastthe last point of detection for this event.A review of the device history record (dhr) for this unit showed no irregularities duringmanufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide in root cause: clotting in the channel could introduce air into the line and trigger an rbc spilloverbecause the channel lines were clotted off.A definitive root cause for clotting could not bedetermined.Possible causes include but are not limited to:¿ excessive pasting or clumping due to donor physiology and/or non-optimal ac ratio.

Event Description

Full patient id: (b)(6) the customer declined to provide patient age.No medical intervention was required for thisevent.

Manufacturer Narrative

This report is being filed to provide further evaluation of this event has determined that the device did not cause or contribute to adeath or serious injury, nor is there a likely potential for death or serious injury associated with thisevent based on additional investigational information.It was determined that air was not past thepoint of last detection, and therefore, could not have been returned to the donor/patient.

Event Description

The customer reported that approximately 77 minutes into a procedure on trima, the nursenoticed aggregation in the collect bag with no alarm and a reported platlet yield of 2.7x10^11.Following this, they received a 'spillover' alarm.The operator selected continue and startedrecovery.It was at this point they noticed air in the collect line during the return cycle.Theoperator stopped the procedure immediately without rinseback.

Manufacturer Narrative

This report is being filed to provide additional information in b.5.Investigation is in process.A follow-up report will be provided.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, PLASMA, AUTO RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8555842
• MDR Text Key: 143594480
• Report Number: 1722028-2019-00099
• 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,Followup,Followup
• Report Date: 04/26/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: 80355
• Device Lot Number: 1802062130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/26/2019
• Supplement Dates Manufacturer Received: 05/14/2019; 06/12/2019; 06/19/2019; 07/15/2019; 07/15/2019
• Supplement Dates FDA Received: 05/21/2019; 06/14/2019; 07/09/2019; 07/15/2019; 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 82