MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLT,PLASMA,ISBT SET

Catalog Number	5803002
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bacterial Infection (1735); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that a patient experienced discomfort during a platelet transfusion on a spectra optia device and the transfusion had to be ended.It was reported that a bacterial culture revealed streptococcus agalactiae in the transfused product.Patient identification and outcome are unknown at this time.Terumo bct is awaiting return of the collection set for evaluation.
Event or Problem Description
The customer reported that a patient experienced discomfort during a platelet transfusion on a spectra optia device and the transfusion had to be ended.It was reported that a bacterial culture revealed streptococcus agalactiae in the transfused product.Per customer donor outcome is "no issues" customer declined to provide patient information.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 b.5, b.6, h.6 and h.11.Investigation: a review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that a patient experienced discomfort during a platelet transfusion on a spectra optia device and the transfusion had to be ended.It was reported that a bacterial culture revealed streptococcus agalactiae in the transfused product.Per customer donor outcome is "no issues" and no medical intervention was reported.Customer declined to provide donor and patient information.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 b.5, d.4, d.9, h.1, h.3, h.6 and h.11.Investigation: a review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found zero (0) other reports for similar issues on this lot.Four unused trima disposable sets were returned for investigation.During the initial evaluation, the tyvek covers were found to be properly sealed.The sets were visually inspected for any misassembly, kinks, or defects, and none were observed.The platelet bags were also inspected for any discoloration or tears, but no issues were found.Subsequently, all platelet bags were leak tested, and no issues were identified.A literature review was conducted for the organism identified by the customer.Per literature review, the pathogen streptococcus agalactiae represents group b streptococcus (gbs).The commonly used term of group b streptococcus or gbs is based on lancefield grouping that takes into account specific cell wall carbohydrate antigens.It is a common colonizer of the genital and gastrointestinal tracts.(hanna m, noor a.Streptococcus group b.[updated 2023 jan 16].In: statpearls [internet].Treasure island (fl): statpearls publishing; 2025 jan-.Available from: https://www.Ncbi.Nlm.Nih.Gov/books/nbk553143/) per and internal report, the phenomenon of bacterial contamination in blood products, especially platelets, is known to occur.With current technologies, given the nature of microorganisms on human skin and the mechanical act of piercing the skin coupled with the fact that platelets must be incubated at room temperature it is not possible to eliminate this phenomenon from occurring.The devices terumo bct manufactures in lakewood / littleton, co, vietnam, costa rica and harmac to collect, separate and store blood products are terminally sterilized to an sal of < 1.0 x 10-6.Additionally, a sterility assurance system has been designed and employed to ensure this sal will be achieved for every product manufactured.Therefore, it may be concluded bacterial contamination observed in collected blood products from terumo bct devices is most likely due to the inherit hazard of collecting blood as it relates to bacterial contamination.Investigation is in process, a follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, e.1, h.6 and h.11.Investigation: a review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found zero (0) other reports for similar issues on this lot.Four unused trima disposable sets were returned for investigation.During the initial evaluation, the tyvek covers were found to be properly sealed.The sets were visually inspected for any misassembly, kinks, or defects, and none were observed.The platelet bags were also inspected for any discoloration or tears, but no issues were found.Subsequently, all platelet bags were leak tested, and no issues were identified.A literature review was conducted for the organism identified by the customer.Per literature review, the pathogen streptococcus agalactiae represents group b streptococcus (gbs).The commonly used term of group b streptococcus or gbs is based on lancefield grouping that takes into account specific cell wall carbohydrate antigens.It is a common colonizer of the genital and gastrointestinal tracts.(hanna m, noor a.Streptococcus group b.[updated 2023 jan 16].In: statpearls [internet].Treasure island (fl): statpearls publishing; 2025 jan-.Available from: https://www.Ncbi.Nlm.Nih.Gov/books/nbk553143/) per and internal report, the phenomenon of bacterial contamination in blood products, especially platelets, is known to occur.With current technologies, given the nature of microorganisms on human skin and the mechanical act of piercing the skin coupled with the fact that platelets must be incubated at room temperature it is not possible to eliminate this phenomenon from occurring.The devices terumo bct manufactures in lakewood / littleton, co, vietnam, costa rica and harmac to collect, separate and store blood products are terminally sterilized to an sal of < 1.0 x 10-6.Additionally, a sterility assurance system has been designed and employed to ensure this sal will be achieved for every product manufactured.Therefore, it may be concluded bacterial contamination observed in collected blood products from terumo bct devices is most likely due to the inherit hazard of collecting blood as it relates to bacterial contamination.Root cause: a root cause assessment was performed for the microbial contamination.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: improper venipuncture technique introduces bacteria at access site resulting in bacterial growth in product bag.Inadequate or no blood diversion performed due to operator error resulting in bacterial contamination of product.Species was endogenous and originated from the donor.Inadequate post-processing laboratory practices such as qc sampling or handling techniques.
Event or Problem Description
The customer reported that a patient experienced discomfort during a platelet transfusion on a spectra optia device and the transfusion had to be ended.It was reported that a bacterial culture revealed streptococcus agalactiae in the transfused product.Per customer donor outcome is "no issues" and no medical intervention was reported.The customer declined to provide donor and patient information.The collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL PLT,PLASMA,ISBT 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: 21806471
• Report Number: 1722028-2025-00084
• Device Sequence Number: 7409136
• Product Code: GKT
• UDI-Device Identifier: 05020583803008
• UDI-Public: 05020583803008
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/09/2025

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: 10/01/2026
• Device Catalogue Number: 5803002
• Device Lot Number: 2410065151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 06/04/2025; 07/04/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/23/2025; 06/17/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• 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