MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLATELET, PLASMA, RBC SET

Model Number	80406
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that air was observed in donor draw/return line after ac was primed during an apheresis platelet procedure.There was no donor information as the procedure was discontinued prior to connecting donor.
Additional Manufacturer Narrative
Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.The disposable set was returned to terumo bct for evaluation.The disposable set was visually evaluated for any misassembly, or defect that could have contributed to the reported incident.Visual evaluation revealed that the ac filter was bonded upside down to the cassette.No other defects were noted during evaluation.Additionally, the 3-1 manifold was checked for leak, none were found.Investigation is in process, a follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 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.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.The disposable set was returned to terumo bct for evaluation.The disposable set was visually evaluated for any misassembly, or defect that could have contributed to the reported incident.Visual evaluation revealed that the ac filter was bonded upside down to the cassette.No other defects were noted during evaluation.Additionally, the 3-1 manifold was checked for leak, none were found.Terumo bct manufacturing staff were made aware of the reported defect.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be a manufacturing error where the ac filter was bonded upside down on the ac line.
Event or Problem Description
The customer reported that air was observed in donor draw/return line after ac was primed during an apheresis platelet procedure.There was no donor information as the procedure was discontinued prior to connecting donor.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 17299703
• Report Number: 1722028-2023-00231
• Device Sequence Number: 3827261
• Product Code: GKT
• UDI-Device Identifier: 05020583804067
• UDI-Public: 05020583804067
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/11/2023

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: 12/01/2024
• Device Model Number: 80406
• Device Catalogue Number: 4824062
• Device Lot Number: 2212206142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown