MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET SAMPLER MULTIPLASMA RBC SET

Model Number 82408

Device Problems Defective Component (2292); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that while setting up the trima device it was found that the white pinch clamp was defective on the sample pouch line.Per the customer the disposable set was not used.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 h.6, h.7 and h.10.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.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 SAMPLER MULTIPLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9429574
• MDR Text Key: 187626741
• Report Number: 1722028-2019-00393
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824089
• UDI-Public: 05020583824089
• 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: 12/06/2019

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: 07/01/2021
• Device Model Number: 82408
• Device Catalogue Number: 82408
• Device Lot Number: 1907301130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other