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

Catalog Number 80337

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591)

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

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the disposable set was returned for evaluation.The customer's statement was confirmed.There was nothing wrong found with the set.The possible root cause was unknown.The run data file was reviewed for this event.The rdf shows a pressure test error due to failing the decay test.The tubing set test positively pressurizes the aps, holds that pressure for a few seconds ensuring no leaks, then the pumps move slightly for the decay test.At this point, the pressure is expected to decrease (or decay) by less than 50mmhg.The alert that occurred here occurs when the pressure drops by more than that during the decay test.Based on the dlog, it looks like at least the needle line clamp was opened to relieve the pressure back to 0, then re-closed, the operator continued, and the tubing set test passed.Per the dlogs, the customer ran a full run with this kit after donor connection too.The alarm screen did not indicated to check for air in the sample bag.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during setup, they received a 'pressure test failure occurred' alarm.Per the customer, they followed the instruction on the screen.When they connected the needle to the donor and opened the clamp on the donor line and diversion bag line, air filled the diversion bag.There had been no air in the bag prior to needle connection.Patient (donor) 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

Investigation : a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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.The customer was retrained at the site by a terumo bct regional specialist.They were informed of the issue and understood.Corrective action: an internal capa has been initiated to address pinch clamp no occluding the sample bag line consistently.Root cause : the pressure test failure alarm occurred because the sample bag line clamp was not closed.Based on the evaluation of the return kit and the analysis of the run data file, it is possible that 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 customer declined to provide patient identifier and age.

Event Description

The customer confirmed that following the procedure the donor was "well".

Manufacturer Narrative

This report is being filed to provide additional information in b.5 and h.6.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10362210
• MDR Text Key: 203539908
• Report Number: 1722028-2020-00359
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: 80337
• Device Lot Number: 2002124151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 73