MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL RBC PLT/PLASMA

Model Number 80400

Device Problems Device Displays Incorrect Message (2591); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the device history record was reviewed for this lot.There were no irregularities noted that would have contributed to this incident.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 they received a pressure test error during set test.The clamps were checked.The system gave the same error again even though the white clamps were closed.The sample bag was found to be swollen.The procedure was discontinued and restarted with a new set.Customer declined to provide patient (donor) identifier due to eu data privacy laws.Donor was not connected at time of incident.The disposable set is not available for return because it was discarded by the customer.

Event Description

No donor was connected at the time of the event, therefore, the patient data that was submitted in the initial mdr is no longer relevant to this event.

Manufacturer Narrative

This report is being filed to provide additional information in a.1, b.5, h.10.Investigation: the customer provided photographs in lieu of the disposable set.The photos confirmed the set was not connected to a donor.There was evidence of air in the sample bag, which confirms the customer description.It is not clear from the photos if the sample line sidewall pinch clamp was damaged and/or closed adequately.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 RBC PLT/PLASMA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10567338
• MDR Text Key: 209412570
• Report Number: 1722028-2020-00453
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804005
• UDI-Public: 05020583804005
• Combination Product (y/n): N
• PMA/PMN Number: BK180231
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: 80400
• Device Catalogue Number: 80400
• Device Lot Number: 1809074151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 86