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

Model Number	12120
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2022
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 a case of positive cultures in an apheresis product.The packaging was intact prior to usage.Patient information and outcome are not available at this time.The apheresis set is not available for return for evaluation.
Additional Manufacturer Narrative
This report is being filed to provide additional information in a.1, b.3, b.5 and h.6.Investigation is in process.A follow up report will be provided.
Event or Problem Description
The customer reported a case of positive cultures in an apheresis product.The customer reported that the product was an un-mobilized mononuclear cell (mnc) collection.The packaging was intact prior to usage.Per the customer, it was growing pseudomonas oryzihabitans on the pre-processing and cryopreservation samples.The patient also grew the same organism from blood cultures that were drawn at the completion of the apheresis procedure.Per the customer the product was not used, no patient information is reasonably known.The apheresis set is not available for return for evaluation.
Event or Problem Description
The customer reported a case of positive cultures in an apheresis product.The customer reported that the product was an un-mobilized mononuclear cell (mnc) collection.The packaging was intact prior to usage.Per the customer, it was growing pseudomonas oryzihabitans on the pre-processing and cryopreservation samples.The patient also grew the same organism from blood cultures that were drawn at the completion of the apheresis procedure.Per the customer the product was not used, no patient information is reasonably known.The apheresis set is not available for return for evaluation.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A literature review was conducted for the organisms identified by the customer.Per literature review, pseudomonas oryzihabitans (p.Oryzihabitans) is the current name for the organism previously called chromobacterium typhiflavum and flavimonas oryzihabitans.(woo et al., 2014) it is a gram-negative and oxidase-negative, non-fermenting bacterium whose colonies are typically yellow-pigmented, rough or wrinkled after 48 h incubation on agar media.P.Oryzihabitans is considered a rare cause of human infections and is most reported in immunocompromised hosts.In hospital setting, p.Oryzihabitans is frequently found in sink drains and/or respiratory equipment, and infections usually occur in cases involving catheters with central venous catheter-related infections reported most frequently.(mari et al., 2000) (woo et al., 2014) per terumo bct 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.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.
Additional Manufacturer Narrative
Investigation: a review of the device history record (dhr) for this unit 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 case of positive cultures in an apheresis product.The customer reported that the product was an un-mobilized mononuclear cell (mnc) collection.The packaging was intact prior to usage.Per the customer, it was growing pseudomonas oryzihabitans on the pre-processing and cryopreservation samples.The patient also grew the same organism from blood cultures that were drawn at the completion of the apheresis procedure.Per the customer the product was not used, no patient information is reasonably known.The apheresis set is not available for return for evaluation.
Event or Problem Description
The customer reported a case of positive cultures in an apheresis product.The customer reported that the product was an un-mobilized mononuclear cell (mnc) collection.The packaging was intact prior to usage.Per the customer, it was growing pseudomonas oryzihabitans on the pre-processing and cryopreservation samples.The patient also grew the same organism from blood cultures that were drawn at the completion of the apheresis procedure.Per the customer the product was not used, no patient information is reasonably known.The apheresis set is not available for return for evaluation.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A literature review was conducted for the organisms identified by the customer.Per literature review, pseudomonas oryzihabitans (p.Oryzihabitans) is the current name for the organism previously called chromobacterium typhiflavum and flavimonas oryzihabitans.(woo et al., 2014) it is a gram-negative and oxidase-negative, non-fermenting bacterium whose colonies are typically yellow-pigmented, rough or wrinkled after 48 h incubation on agar media.P.Oryzihabitans is considered a rare cause of human infections and is most reported in immunocompromised hosts.In hospital setting, p.Oryzihabitans is frequently found in sink drains and/or respiratory equipment, and infections usually occur in cases involving catheters with central venous catheter-related infections reported most frequently.(mari et al., 2000) (woo et al., 2014) per terumo bct 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.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.Complications associated with prolonged use of central venous access.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.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA COLLECT 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: 16062014
• Report Number: 1722028-2022-00427
• Device Sequence Number: 19806453
• Product Code: LKN
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK150251
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/28/2022
• 2 Devices were Involved in the Event: 1 2

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: 01/02/2024
• Device Model Number: 12120
• Device Catalogue Number: 4121201
• Device Lot Number: 2201281161
• 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: 12/06/2022
• Supplement Date Received by Manufacturer: 01/18/2023; 03/17/2023; 04/24/2023; 06/15/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 01/20/2023; 04/04/2023; 04/27/2023; 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2022
• 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