MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA IDL SET

Catalog Number	4123201
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
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 during a cellular therapy collection on a spectra optia device, a positive culture for salmonella enterica ssp enterica was identified on the second day of collection using bact testing procedures.Per the customer, the patient exhibited no symptoms on either the first or second day of collection.Additionally, the customer collected cultures from the patient¿s lines (tip, red lumen and right arm), with negative results.The patient was reported to have no signs or symptoms of infection, showed ¿no change¿, and no medical intervention was reported.Unit id: (b)(6) 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, h.6, and h.11.Investigation: a literature review was conducted for the organisms identified by the customer.Salmonella enterica subsp.Enterica is a subspecies of the salmonella enterica species, a type of bacterium that is a common cause of foodborne illness in humans and animals.It is a gram-negative, rod-shaped bacterium that can cause gastrointestinal diseases, such as gastroenteritis, in humans.This pathogen is found in the intestines of a variety of animals, particularly poultry, and can be transmitted to humans primarily through the consumption of contaminated food or water, particularly meat, eggs, and dairy products.The disease caused by s.Enterica subsp.Enterica is typically referred to as salmonellosis.Salmonellosis is a major cause of bacterial enteric illness in both humans and animals.Each year an estimated 1.4 million cases of salmonellosis occur among humans in the united states.The majority (59%) of the 2,463 salmonella serotypes belong to s.Enterica subsp.I (s.Enterica subsp.Enterica).Within s.Enterica subsp.I, the most common o-antigen serogroups are a, b, c1, c2, d and e.Strains in these serogroups cause approximately 99% of salmonella infections in humans and warm-blooded animals.(brenner et al., 2000) there are 0.2-micron filter on both the acda and saline lines so the likelihood of introducing bacteria through these two routes are unlikely.A batch document review of acda lot provided by the customer identified no other related complaints, no allegations of potential contamination and all lots manufactured passed all in-house quality testing and went through the steam sterilization process.Per a 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.A disposable complaint history search was performed for this lot and for the acda lot provided by the customer and found no other report for similar issues on this lot.A review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.Root cause: a root cause assessment was performed for the microbial contamination.It was reported that a positive culture of salmonella enterica ssp enterica was cultured from the patient product on during the second day of collection.Contracting salmonella spp.During apheresis is highly unlikely under typical, well-regulated conditions.However, there are a few potential indirect pathways that could theoretically lead to a salmonella infection in an apheresis setting.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.* patients' underlying disease diagnosis (immunocompromised host) and/or the species was endogenous and originated from the patient.* inadequate post-processing laboratory practices such as qc sampling or handling techniques.* false positives due to initial sampling techniques/aseptic sampling techniques.Bibliography mari, m., garci, o., viedma, a.De, marti, p., rodri, m., ixems, g., & bouza, e.(2000).Infection of hickman catheter by pseudomonas (formerly flavimonas) oryzihabitans traced to a synthetic bath sponge.In journal of clinical microbiology (vol.38, issue 12).Https://journals.Asm.Org/journal/jcm woo, k.S., choi, j.L., kim, b.R., kim, j.E., kim, k.H., kim, j.M., & han, j.Y.(2014).Outbreak of pseudomonas oryzihabitans pseudobacteremia related to contaminated equipment in an emergency room of a tertiary hospital in korea.Infection and chemotherapy, 46(1), 42¿44.Https://doi.Org/10.3947/ic.2014.46.1.42.
Event or Problem Description
The customer reported that during a cellular therapy collection on a spectra optia device, a positive culture for salmonella enterica ssp enterica was identified on the second day of collection using bact testing procedures.Per the customer, the patient exhibited no symptoms on either the first or second day of collection.Additionally, the customer collected cultures from the patient¿s lines (tip, red lumen and right arm), with negative results.The patient was reported to have no signs or symptoms of infection, showed ¿no change¿, and no medical intervention was reported.Full patient unit id: (b)(6) the collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA IDL 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: 20914667
• Report Number: 1722028-2024-00551
• Device Sequence Number: 20982506
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K183081
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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: 05/01/2026
• Device Catalogue Number: 4123201
• Device Lot Number: 2405293141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2024
• 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 Age: 51 YR
• Patient Sex: Male