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

Catalog Number 80337

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Pressure Problem (3012)

Patient Problem No Patient Involvement (2645)

Event Date 08/15/2020

Event Type  malfunction  

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.The disposable set was returned for evaluation.Terumo bct japan has confirmed the customer¿s statement and found the following: there was not anything wrong on the returned set.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 not occluding the sample bag line consistently.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during set up, the trima device gave a pressure test failure alarm.The customer then saw that the diversion bag was filled with air.There was not a donor connected during this event, therefore donor (patient) information is not reasonably known.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: tbct japan returned the part to lakewood for investigation.The set was visually inspected for kinks, occlusions, missing parts, mis-assembly or leaks which may have contributed to the reported incident.The white sidewall pinch clamp showed some minor damage on one side.The set was received with no air in the diversion bag.All pressure sensors were inspected and determined to be functioning properly.The set was loaded onto the trima machine in the lab with clamps in their "as found" position.The set passed loading, tubing set test and made it to the connect ac stage.The procedure was halted at this point and the set was unloaded.No alarms or errors were encountered.No air went into the diversion bag during the test.Root cause: 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, or the clamp does not fully occlude the tubing when closed due to interference between the clamp and the tube.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.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10508103
• MDR Text Key: 206187058
• Report Number: 1722028-2020-00432
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

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: 03/01/2022
• Device Catalogue Number: 80337
• Device Lot Number: 2003024251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other