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

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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
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 a bacterial contamination in platelet product in a double platelet product collected on (b)(6) 2025.Per customer, on (b)(6) 2025 when they intended to send the platelets out, fibrin precipitation was detected and bacterial culture revealed citrobacter koseri.There was not a transfusion recipient or patient involved at the time of the contamination testing; therefore, no patient information is reasonably known at the time of the event.Terumo bct is awaiting return of the disposable set for evaluation.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, d.4, e.1, h.3, d.9, 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.The customer submitted a video showing clotting in the platelet units.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, citrobacter koseri, formerly known as citrobacter diversus, is a bacterium of the citrobacter genus.It is a common rod-shaped, gram-negative, facultative anaerobic bacillus.It is a typical inhabitant of the human digestive tract and may be found in a variety of foods, soil, and water in the environment.Despite being categorized as an opportunistic pathogen, c.Koseri can cause devastating infections, especially in immunocompromised and neonatal patients.The bacteria can spread from person to person, particularly in hospital environments, by contaminated food or drink, the fecal-oral pathway, or interpersonal contact.Alhaidhal, b.A., alsulais, f.M., mothana, r.A.Et al.In silico discovery of druggable targets in citrobacter koseri using echinoderm metabolites and molecular dynamics simulation.Sci rep 14, 26776 (2024).Https://doi.Org/10.1038/s41598-024-77342-5 per an internal technical 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.
Event or Problem Description
The customer reported a bacterial contamination in platelet product in a double platelet product collected on (b)(6) 2025.Per customer, on (b)(6) 2025 when they intended to send the platelets out, fibrin precipitation was detected and bacterial culture revealed citrobacter koseri and klebsiella oxytoca.There was not a transfusion recipient or patient involved at the time of the contamination testing; therefore, no patient information is reasonably known at the time of the event.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, 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.The customer submitted a video showing clotting in the platelet units.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, klebsiella species are becoming an important pathogen of humans, and are being implicated in increasing morbidity amongst the patient population.Normally found in bowel of man and animals, water and soil, infections with these bacteria are leading to prolonged stays in hospitals.Multiple comorbidities and compromised immune status along with exposures to multiple antibiotics are main factors that increase the risks for infections and drug resistance.Colonization of the respiratory and the gastro-intestinal tract is common in hospitalised patients.Thus, klebsiella species are often a cause of bronchopneumonia, urinary tract infection and septicaemia in admitted patients.This bacterium has the ability to cause outbreaks of nosocomial infection as it often exchanges plasmid-borne resistance with other bacteria, which are more common at tertiary and specialized centres.Klebsiella pneumoniae is the single, predominant species gaining more significance as it is developing multidrug resistance at tertiary care centres similar to pseudomonas and acinetobacter.Among the klebsiella, k.Oxytoca is now being isolated more frequently.This was earlier named bacterium oxytocum by flugge in 1886 and is an organism that forms indole, has a positive voges¿proskauer reaction and liquefies gelatine along with other features of klebsiella species.K.Oxytoca is normally acquired from environmental sources.Some previous studies have concluded its pathogenic significance in sputum and blood culture in a few patients, while uncertain in others, more so in respiratory infections.(singh l, cariappa mp, kaur m.Klebsiella oxytoca: an emerging pathogen? med j armed forces india.2016 dec;72(suppl 1):s59-s61.Doi: 10.1016/j.Mjafi.2016.05.002.Epub 2016 jun 14.Pmid: 28050072; pmcid: pmc5192185).Per an internal technical 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.Based on the available information a definitive root cause for the platelet clotting could not be determined but it is likely due to one or a combination of the possible causes listed below: improper anticoagulation of the extra corporeal system.The donor's physiology.
Event or Problem Description
The customer reported a bacterial contamination in platelet product in a double platelet product collected on (b)(6) 2025.Per customer, on (b)(6) 2025 when they intended to send the platelets out, fibrin precipitation was detected and bacterial culture revealed citrobacter koseri and klebsiella oxytoca.There was not a transfusion recipient or patient involved at the time of the contamination testing, therefore no patient information is reasonably known at the time of the event.The customer declined to provide any information about the donor.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL PLT,PLASMA,ISBT
• 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: 21806931
• Report Number: 1722028-2025-00085
• Device Sequence Number: 21085032
• 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
• 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: 06/04/2025; 07/04/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 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