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

Model Number	82700
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that the plasma and red blood cell (rbc) lines were switched on a trima device.The customer reported that 635ml of 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.
Additional Manufacturer Narrative
This report is being filed to provide additional information in a.1, a2, a.3, a.4, 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.
Event or Problem Description
Low hematorcrit red blood cells were collected instead of plasma from the donor.No clinical consequences were reported.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL MULTIPLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11321326
• Report Number: 1722028-2021-00065
• Device Sequence Number: 934123
• Product Code: GKT
• UDI-Device Identifier: 05020583827004
• UDI-Public: 05020583827004
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Weight: 66