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

Catalog Number 80337

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the disposable set was returned toterumo bct japan for evaluation.Upon evaluation, the customer¿s statement was confirmed and the diversion bag was found to be inflated.There were no issues noted with the clamp on the diversion bag line was.Tbct japan returned the part to terumo bct for further investigation.Observations were consistent with the results from the tbct japan evaluation.Air was noted in the blood diversion bag.Additionally, the sidewall clamp shows no signs of damage to the sidewalls.The air in the blood diversion bag is contained by the clamps.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during disposables set-up, the alarm 'pressure test failure' occurred.Upon return of the disposables set to terumo bct japan, the diversion bag was found to be inflated with air.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 information in a.1, e.1 and e.3, and additional information in b.5, e.1, h.6, and h.10.Full address for section e.1: (b)(6).(b)(6).Investigation: terumo bct lakewood evaluated the disposable set and the findings were consistent with the results from the tbct japan findings.Air was noted in the blood diversion bag.Additionally, the sidewall clamp shows no signs of damage to the sidewalls and were determined to fully occlude.The air in the blood diversion bag is contained by the clamps.The returned set was loaded onto the trima machine in the lab and all on screen prompts for clamping were followed.The set passed loading, tubing set test and made it to the connect ac stage.The procedure was halted atthis point and the set was unloaded.No alarms or errors were encountered.The device history record (dhr) was reviewed for this lot.There were no issuses noted in the dhr that would have contributed to the air as experienced by the customer.Correction: trima field action 35 has been initiated to notify all trima users of a potential safety hazard occurs if the system displays an alert and instructions are not observed and followed.Terumo bct is taking corrective action by reminding all users of the action to be taken to mitigate this risk.Alerts and instructions are presented to the operator if the sample bag inflates.Terumo bct instructs all trima users to provide supplementary training and to continue to use the trima accel system in accordance with the operator¿s manual.Corrective action: an internal capa has been initiated to address pinch clamp no occluding the sample bag line consistently.Root cause: a specific root cause could not be definitively determined for this incident.Possible causes include: a clamp malfunction where the clamp skews to the side as it is closed.Additional contributing factors could be related to user interface, where either the sample bag clamp was not closed at the system prompt or the clamp was closed, but it was skewed on the tubing enabling a portion of the tubing to allow air to pass.

Event Description

The procedure was disconnected prior to connecting a donor, therefore no patient information was provided.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9739826
• MDR Text Key: 185698097
• Report Number: 1722028-2020-00077
• 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
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Catalogue Number: 80337
• Device Lot Number: 1907235151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other