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

Model Number 12320

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 12/07/2022

Event Type  Injury  

Event Description

The customer reported following a post human peripheral blood progenitor cell (hpbpc) collection, a patient had a line infection with salmonella species group b using bactec fx testing.Root cause was unable to be established by the customer.The patient was admitted and treated for bacteremia.Peripheral and repeat initial product cultures did not grow.The only product that grew was the plasma reduced initial product culture.Per follow-up with the customer, the cultures have been recollected last week ¿ results unknown (patient no longer at this institution but will return for collection).The unit is currently in cryopreservation.They are not intending to use the product unless recollection does not provide the dose needed.Patient pending recollection of autologous product.The customer declined to provide patient information.The collection set is not available for return for evaluation.

Manufacturer Narrative

Investigation is in process.A follow up report will be provided.

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.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported following a post human peripheral blood progenitor cell (hpbpc) collection, a patient had a line infection with salmonella species group b using bactec fx testing.Root cause was unable to be established by the customer.The patient was admitted and treated for bacteremia.Peripheral and repeat initial product cultures did not grow.The only product that grew was the plasma reduced initial product culture.Per follow-up with the customer, the cultures have been recollected last week ¿ results unknown (patient no longer at this institution but will return for collection).The unit is currently in cryopreservation.They are not intending to use the produnt unless recollection does not provide the dose needed.Patient pending recollection of autologous product.The customer declined to provide patient information.The collection set is not available for return for evaluation.

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.The disposable set was discarded and therefore an evaluation could not be conducted.The product is in in cryopreservation with no intention for use.The customer provided a report outlining the clinical laboratory results documenting the gram stain result of gram-negative rods in aerobic bottle from the initial culture.Detection time was 16 hour and 9 minutes and the report status identified salmonella group b.The was no growth from the catheter tip, peripherally and line drawn blood, or from the final and repeat human peripheral blood progenitor cells cultures.A disposable complaint history search was performed for this lot and found no other report for similar issues on this lot.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported following a post human peripheral blood progenitor cell (hpbpc) collection, a patient had a line infection with salmonella species group b using bactec fx testing.Root cause was unable to be established by the customer.The patient was admitted and treated for bacteremia.Peripheral and repeat initial product cultures did not grow.The only product that grew was the plasma reduced initial product culture.Per follow-up with the customer, the cultures have been recollected last week ¿ results unknown (patient no longer at this institution but will return for collection).The unit is currently in cryopreservation.They are not intending to use the produnt unless recollection does not provide the dose needed.Patient pending recollection of autologous product.The customer declined to provide patient information.The collection set is not available for return for evaluation.

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.The disposable set was discarded and therefore an evaluation could not be conducted.The product is in in cryopreservation with no intention for use.The customer provided a report outlining the clinical laboratory results documenting the gram stain result of gram-negative rods in aerobic bottle from the initial culture.Detection time was 16 hour and 9 minutes and the report status identified salmonella group b.The was no growth from the catheter tip, peripherally and line drawn blood, or from the final and repeat human peripheral blood progenitor cells cultures.A disposable complaint history search was performed for this lot and found no other report for similar issues on this lot.A literature review was conducted for the organisms identified by the customer.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) per literature review, salmonella are a genus of gram-negative bacteria that typically colonize the gastrointestinal tract of animals and humans.Typing of salmonella for specific identification into serotypes requires an assortment of antisera such as single factor o-antisera as well as phase 1 and phase 2 h-typing antisera.There are over 1800 known serovars which current classification considers to be separate species (ralph a.Giannella., 1996) the patient was reportedly admitted for treatment for bacteremia.Bacteremia is the presence of viable bacteria in the circulating blood.Most episodes of occult bacteremia spontaneously resolve, particularly those caused by streptococcus pneumoniae and salmonella, and serious sequelae are increasingly uncommon.Bacteremia, in the strictest sense, refers to viable bacteria in the blood.Asymptomatic bacteremia can occur in normal daily activities such as conducting oral hygiene and after minor medical procedures.In a healthy person, these clinically benign infections are transient and cause no further sequelae.However, when immune response mechanisms fail or become overwhelmed, bacteremia becomes a bloodstream infection that can evolve into many clinical spectrums and is differentiated as septicemia.(smith & nehring, 2022) determining the primary source of infection is critical in the management of a patient with bacteremia, as well as in the identification of the affected patient population.Common sources in hospitalized patients include the respiratory tract and indwelling catheters, specifically central venous catheters.(smith & nehring, 2022) 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.Brenner, f.W., villar, r.G., angulo, f.J., tauxe, r., & swaminathan, b.(2000).Guest commentary salmonella nomenclature.In journal of clinical microbiology (vol.38, issue 7).Ralph a.Giannella.(1996).Medical microbiology (baron s, ed.; 4th ed.).University of texas medical branch at galveston.Https://www.Ncbi.Nlm.Nih.Gov/books/nbk8435/ smith, d.A., & nehring, s.M.(2022).Bacteremia.Pediatric emergency medicine, 530¿534.Https://doi.Org/10.1016/b978-141600087-7.50071-4.

Event Description

The customer reported following a post human peripheral blood progenitor cell (hpbpc) collection, a patient had a line infection with salmonella species group b using bactec fx testing.Root cause was unable to be established by the customer.The patient was admitted and treated for bacteremia.Peripheral and repeat initial product cultures did not grow.The only product that grew was the plasma reduced initial product culture.Per follow-up with the customer, the cultures have been recollected last week ¿ results unknown (patient no longer at this institution but will return for collection).The unit is currently in cryopreservation.They are not intending to use the produnt unless recollection does not provide the dose needed.Patient pending recollection of autologous product.The customer declined to provide patient information.The collection set is not available for return for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information in 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.The disposable set was discarded and therefore an evaluation could not be conducted.The product is in in cryopreservation with no intention for use.The customer provided a report outlining the clinical laboratory results documenting the gram stain result of gram-negative rods in aerobic bottle from the initial culture.Detection time was 16 hour and 9 minutes and the report status identified salmonella group b.The was no growth from the catheter tip, peripherally and line drawn blood, or from the final and repeat human peripheral blood progenitor cells cultures.A disposable complaint history search was performed for this lot and found no other report for similar issues on this lot.A literature review was conducted for the organisms identified by the customer.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) per literature review, salmonella are a genus of gram-negative bacteria that typically colonize the gastrointestinal tract of animals and humans.Typing of salmonella for specific identification into serotypes requires an assortment of antisera such as single factor o-antisera as well as phase 1 and phase 2 h-typing antisera.There are over 1800 known serovars which current classification considers to be separate species (ralph a.Giannella., 1996) the patient was reportedly admitted for treatment for bacteremia.Bacteremia is the presence of viable bacteria in the circulating blood.Most episodes of occult bacteremia spontaneously resolve, particularly those caused by streptococcus pneumoniae and salmonella, and serious sequelae are increasingly uncommon.Bacteremia, in the strictest sense, refers to viable bacteria in the blood.Asymptomatic bacteremia can occur in normal daily activities such as conducting oral hygiene and after minor medical procedures.In a healthy person, these clinically benign infections are transient and cause no further sequelae.However, when immune response mechanisms fail or become overwhelmed, bacteremia becomes a bloodstream infection that can evolve into many clinical spectrums and is differentiated as septicemia.(smith & nehring, 2022) determining the primary source of infection is critical in the management of a patient with bacteremia, as well as in the identification of the affected patient population.Common sources in hospitalized patients include the respiratory tract and indwelling catheters, specifically central venous catheters.(smith & nehring, 2022) 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.It was reported that the only product that grew was the plasma reduced initial product culture.Peripheral and repeat initial product cultures did not grow.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: * inadequate maintenance of the patient¿s central venous access.* inadequate post-processing laboratory practices such as qc sampling or handling techniques.* false positives due to initial sampling techniques/aseptic sampling techniques.* patients' underlying disease diagnosis (immunocompromised host) and/or the species was endogenous and originated from the patient.Brenner, f.W., villar, r.G., angulo, f.J., tauxe, r., & swaminathan, b.(2000).Guest commentary salmonella nomenclature.In journal of clinical microbiology (vol.38, issue 7).Ralph a.Giannella.(1996).Medical microbiology (baron s, ed.; 4th ed.).University of texas medical branch at galveston.Https://www.Ncbi.Nlm.Nih.Gov/books/nbk8435/ smith, d.A., & nehring, s.M.(2022).Bacteremia.Pediatric emergency medicine, 530¿534.Https://doi.Org/10.1016/b978-141600087-7.50071-4.

Event Description

The customer reported following a post human peripheral blood progenitor cell (hpbpc) collection, a patient had a line infection with salmonella species group b using bactec fx testing.Root cause was unable to be established by the customer.The patient was admitted and treated for bacteremia.Peripheral and repeat initial product cultures did not grow.The only product that grew was the plasma reduced initial product culture.Per follow-up with the customer, the cultures have been recollected last week ¿ results unknown (patient no longer at this institution but will return for collection).The unit is currently in cryopreservation.They are not intending to use the produnt unless recollection does not provide the dose needed.Patient pending recollection of autologous product.The customer declined to provide patient information.The collection set is not available for return for evaluation.

• Brand Name: SPECTRA OPTIA
• Type of Device: 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: 16207382
• MDR Text Key: 307718236
• Report Number: 1722028-2023-00020
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 12320
• Device Catalogue Number: 4123201
• Device Lot Number: 2208126141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 03/31/2023; 04/07/2023; 04/24/2023; 06/16/2023
• Supplement Dates FDA Received: 04/03/2023; 04/27/2023; 05/22/2023; 06/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention