MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL MULTIPLASMA SET

Model Number 82700

Device Problem Misassembled (1398)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: a photograph was submitted in lieu of the disposable set to aid in the investigation.Analysis of the image revealed a used trima cassette assembly.The red inlet and large clear rbc lines are confirmed switched and bonded into the opposite bond sockets.Based on the available evidence in the image provided, the root cause of the reported failure was a manufacturing mis-assembly.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the plasma and red blood cell (rbc) lines were switched on a trima device.The customer reported that rbcs were collected from the donor.Patient information and outcome are not available at this time.The collection set is not available for return because it was discarded by the customer.

Event Description

The set was not used, therefore no patient information is reasonably known.Patient gender and weight included in a.3 and a.4 due to system limitation and are not relevant to this event.

Manufacturer Narrative

This report is being filed to provide additional information in a.1, b.5, h.6, and h.10.Investigation: the device history record was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the event.Correction: terumo bct has implemented a correction for this incident.Manufacturing staff were made aware of this issue and retrained to the appropriate procedures.Corrective action: an internal capa has been initiated to address an increase in reports of trima misassembly of 4-lumen tubing.Root cause: the cause of this defect was related to a misassembly, where the assembler neglected to follow the appropriate manufacturing operating procedure of the disposable set during manufacturing.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL MULTIPLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11317369
• MDR Text Key: 243759986
• Report Number: 1722028-2021-00066
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583827004
• UDI-Public: 05020583827004
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: 82700
• Device Catalogue Number: 82700
• Device Lot Number: 2012152130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 70