MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL RBC PLT/PLASMA

Catalog Number	80400
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	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per journal article "posttransfusion sepsis attributable to bacterial contamination in platelet collection set manufacturing facility, united states" by ian kracalik, et all.During (b)(6) 2022, we reviewed transfusion-transmitted sepsis cases in the united states attributable to polymicrobial contaminated apheresis platelet components, including acinetobacter calcoaceticus baumannii complex or staphylococcus saprophyticus isolated from patients and components.Transfused platelet components underwent bacterial risk control strategies (primary culture, pathogen reduction or primary culture, and secondary rapid test) before transfusion.Environmental samples were collected from a platelet collection set manufacturing facility.Seven sepsis cases from 6 platelet donations from 6 different donors were identified in patients from 6 states; 3 patients died.Cultures identified acinetobacter calcoaceticus baumannii complex in 6 patients and 6 transfused platelets, s.Saprophyticus in 4 patients and 4 transfused platelets.Whole-genome sequencing showed environmental isolates from the manufacturer were closely related genetically to patient and platelet isolates, indicating the manufacturer was the most probable source of recurrent polymicrobial contamination.Clinicians should maintain awareness of possible transfusion-transmitted sepsis even when using bacterial risk control strategies.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.Patient information is unknown at this time.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Lot number and expiry information are not available at this time.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, h.10 and h.11.Lot number and expiry information are not available at this time.It has been determined that the event submitted on this report is a duplicate of the event submitted on report 1722028-2024-00088.No further reporting will be provided as this does not represent a reportable event.
Event or Problem Description
Per journal article "posttransfusion sepsis attributable to bacterial contamination in platelet collection set manufacturing facility, united states" by ian kracalik, et all.During may 2018.December 2022, we reviewed transfusion-transmitted sepsis cases in the united states attributable to polymicrobial contaminated apheresis platelet components, including acinetobacter calcoaceticus baumannii complex or staphylococcus saprophyticus isolated from patients and components.Transfused platelet components underwent bacterial risk control strategies (primary culture, pathogen reduction or primary culture, and secondary rapid test) before transfusion.Environmental samples were collected from a platelet collection set manufacturing facility.Seven sepsis cases from 6 platelet donations from 6 different donors were identified in patients from 6 states; 3 patients died.Cultures identified acinetobacter calcoaceticus baumannii complex in 6 patients and 6 transfused platelets, s.Saprophyticus in 4 patients and 4 transfused platelets.Whole-genome sequencing showed environmental isolates from the manufacturer were closely related genetically to patient and platelet isolates, indicating the manufacturer was the most probable source of recurrent polymicrobial contamination.Clinicians should maintain awareness of possible transfusion-transmitted sepsis even when using bacterial risk control strategies.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.Patient information is unknown at this time.The collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL RBC PLT/PLASMA
• 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: 17671711
• Report Number: 1722028-2023-00295
• Device Sequence Number: 6032659
• Product Code: GKT
• UDI-Device Identifier: 05020583804005
• UDI-Public: 05020583804005
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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 Catalogue Number: 80400
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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