MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET, PLASMA SET(ISBT)

Model Number 80300

Device Problems Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during the tubing set test on a trima device prior to a procedure, the sample bag inflated with air.Per the customer, the operator checked the tubing set and found the clamp on tubing line to the sample bag could not be closed firmly.The operator changed to new set.No patient (donor) was connected at the time of the event, therefore, no patient information is available.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in e.1, e.3, h.6 and h.10.Investigation: the customer submitted one photograph with the complaint submission to supplement the investigation.The photograph confirmed the diversion pouch was inflated with air.The sidewall pinch clamp was laid on its side, so it is only possible to confirm that one side of the sidewall pinch clamp was in closed position on the diversion pouch tubing line.It is not possible to confirm if the other side of the sidewall pinch clamp was skewed across the tubing.The tubing set was noted to be unused.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to this event.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 evaluate the sidewall pinch clamp and air in the sample bag.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(ISBT)
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9525820
• MDR Text Key: 186850282
• Report Number: 1722028-2019-00439
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583803008
• UDI-Public: 05020583803008
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• 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: 12/27/2019

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: 08/01/2021
• Device Model Number: 80300
• Device Catalogue Number: 80300
• Device Lot Number: 1908165151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other