MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT, AUTOPAS, PLS, AUTORBC SET

Catalog Number	4824702
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that a trima red blood cell (rbc) product has been identified with hemolysis present during storage.No patient (donor) was connected at the time of the event, therefore, no patient information is available.The collection set is not available for return because it was discarded by the customer.Donor unit #: (b)(6).
Additional Manufacturer Narrative
Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Per the customer, it was confirmed that the hemolysis is below 1% for this event.No further reporting will be provided as this does not represent a reportable event.
Event or Problem Description
The customer reported that a trima red blood cell (rbc) product has been identified with hemolysis present during storage.No patient (donor) was connected at the time of the event; therefore, no patient information is available.The collection set is not available for return because it was discarded by the customer.Donor unit #: (b)(6).

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA PLT, AUTOPAS, PLS, AUTORBC 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: 19354614
• Report Number: 1722028-2024-00179
• Device Sequence Number: 7688571
• Product Code: GKT
• UDI-Device Identifier: 05020583824706
• UDI-Public: 05020583824706
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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: 08/01/2025
• Device Catalogue Number: 4824702
• Device Lot Number: 2308281142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2023
• 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