MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT SAMPLER AUTOPAS MULTIPLS

Catalog Number 80310

Device Problems Leak/Splash (1354); Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Chills (2191)

Event Date 02/03/2023

Event Type  malfunction  

Event Description

The customer reported that the trima set was found to have a leak at the 3-way joint.The customer sent the platelet bag into the system for testing.On (b)(6) 2023, this platelet bag passed the test and then the hospital used it with a patient.After patient received the platelets, the patient developed chills.The doctor sent the platelet bag for testing again, and the test resulted with bacillus cereus and pseudohyphae was found in the gram stain.The patient was tested, and at 11 hrs, the culture result showed positive for gram-positive bacilli.Patient information is not available at this time.The platelet set is not available for return for evaluation.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

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.In lieu of the disposable set, the customer supplied 5 images to aid the investigation.The first captured the tyvek lid of the trima set, confirming the batch and material number.The remaining 4 images captured positive cultures and/or gram stains of gram-positive slender bacilli with rounded ends singly, in pairs, and in short chains.Pseudohyphae formation was confirmed by the yeasts in the gram stain, confirming the alleged microbial contamination experienced by the customer.As per the trima accel disposable tubing sets instructions for use, if the integrity of the tubing set is compromised for any reason, the tubing set is no longer functionally closed, and the product should not be stored beyond 24 hours.It is not known how long into the procedure the leak was detected.It is also not known how long post collection and post initial bacterium testing, that the product was transfused to the recipient.A literature review was conducted for the organisms identified by the customer per literature review, bacillus organisms are widely distributed in the environment although the primary habitat is the soil.These organisms are usually found in decaying organic matter, dust, vegetable, water, and some species are part of the normal flora.In the clinical setting, outbreaks and pseudo epidemic have been traced to contaminated ventilator equipment, disinfectant (ethyl alcohol), hospital linen and dialysis equipment.Due to a combination of recent advances in medical technology and an increased number of immunosuppressed patients, bacillus organisms have been increasingly recognized as opportunistic pathogens in the hospitalized patient.(bacillus species - infectious disease and antimicrobial agents, n.D.) per literature review, bacillus cereus (b.Cereus) is a gram-positive, aerobic-to-facultative, spore-forming rod widely distributed environmentally and bearing a close phenotypic and genetic (16s rrna) relationship to several other bacillus species.(bottone, 2010) in addition to food poisoning, b.Cereus causes a number of systemic and local infections in both immunologically compromised and immunocompetent individuals.Among those most commonly infected are neonates, intravenous drug abusers, patients sustaining traumatic or surgical wounds, and those with indwelling catheters.Pseudohyphae are formed by a wide variety of yeast species including most pathogenic candida species and many pleiomorphic fungi that exhibit transitions between filamentous and unicellular forms of growth.(veses & gow, 2009) per internal technical review, 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.Citation: bacillus species - infectious disease and antimicrobial agents.(n.D.).Retrieved april 14, 2023, from http://www.Antimicrobe.Org/b82.Asp bottone, e.J.(2010).Bacillus cereus, a volatile human pathogen.In clinical microbiology reviews (vol.23, issue 2, pp.382, 398).Https://doi.Org/10.1128/cmr.00073-09 veses, v., & gow, n.A.R.(2009).Pseudohypha budding patterns of candida albicans.Medical mycology, 47(3), 268,275.Https://doi.Org/10.1080/13693780802245474 root cause: a root cause assessment was performed for the microbial contamination.A definitive root cause for the contaminated products could not be determined.Possible causes include but are not limited to: the species was endogenous and originated from the donor.Leak in the disposable set where bacteria may have been introduced and an extended length of time between collection and transfusion (more than 24h) improper venipuncture technique introduces bacteria at access site resulting in bacterial growth in product bag.Inadequate post-processing laboratory practices such as qc sampling or handling techniques.Improper venipuncture technique and no blood diversion performed due to operator error resulting in bacterial contamination of product.The disposable set was not returned for investigation; therefore, a definitive root cause could not be determined for the reported leak.Possible causes include but are not limited to a molding issue resulting in a leak pathway, inadequate contact of the tubing with the bond socket after solvent application and/or inadequate insertion depth of the tubing line into the bond socket.

Event Description

The customer reported that the trima set was found to have a leak at the 3-way joint.The customer sent the platelet bag into the system for testing.On (b)(6) 2023, this platelet bag passed the test and then the hospital used it with a patient.After patient received the platelets, the patient developed chills.The doctor sent the platelet bag for testing again, and the test resulted with bacillus cereus and pseudohyphae was found in the gram stain.The patient was tested, and at 11 hrs, the culture result showed positive for gram-positive bacilli.The customer confirmed that they don't know what the medical intervention was given to the recipient.Patient weight is not available.The platelet set is not available for return for evaluation.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Event Description

The customer reported that the trima set was found to have a leak at the 3-way joint.The customer sent the platelet bag into the system for testing.On (b)(6) 2023, this platelet bag passed the test and then the hospital used it with a patient.After patient received the platelets, the patient developed chills.The doctor sent the platelet bag for testing again, and the test resulted with bacillus cereus and pseudohyphae was found in the gram stain.The patient was tested, and at 11 hrs, the culture result showed positive for gram-positive bacilli.Patient information is not available at this time.The platelet set is not available for return for evaluation.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

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.In lieu of the disposable set, the customer supplied 5 images to aid the investigation.The first captured the tyvek lid of the trima set, confirming the batch and material number.The remaining 4 images captured positive cultures and/or gram stains of gram-positive slender bacilli with rounded ends singly, in pairs, and in short chains.Pseudohyphae formation was confirmed by the yeasts in the gram stain, confirming the alleged microbial contamination experienced by the customer.Investigation is in process.A follow up report will be provided.

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.In lieu of the disposable set, the customer supplied 5 images to aid the investigation.The first captured the tyvek lid of the trima set, confirming the batch and material number.The remaining 4 images captured positive cultures and/or gram stains of gram-positive slender bacilli with rounded ends singly, in pairs, and in short chains.Pseudohyphae formation was confirmed by the yeasts in the gram stain, confirming the alleged microbial contamination experienced by the customer.As per the trima accel disposable tubing sets instructions for use, if the integrity of the tubing set is compromised for any reason, the tubing set is no longer functionally closed, and the product should not be stored beyond 24 hours.It is not known how long into the procedure the leak was detected.It is also not known how long post collection and post initial bacterium testing, that the product was transfused to the recipient.A literature review was conducted for the organisms identified by the customer per literature review, bacillus organisms are widely distributed in the environment although the primary habitat is the soil.These organisms are usually found in decaying organic matter, dust, vegetable, water, and some species are part of the normal flora.In the clinical setting, outbreaks and pseudo epidemic have been traced to contaminated ventilator equipment, disinfectant (ethyl alcohol), hospital linen and dialysis equipment.Due to a combination of recent advances in medical technology and an increased number of immunosuppressed patients, bacillus organisms have been increasingly recognized as opportunistic pathogens in the hospitalized patient.(bacillus species - infectious disease and antimicrobial agents, n.D.) per literature review, bacillus cereus (b.Cereus) is a gram-positive, aerobic-to-facultative, spore-forming rod widely distributed environmentally and bearing a close phenotypic and genetic (16s rrna) relationship to several other bacillus species.(bottone, 2010) in addition to food poisoning, b.Cereus causes a number of systemic and local infections in both immunologically compromised and immunocompetent individuals.Among those most commonly infected are neonates, intravenous drug abusers, patients sustaining traumatic or surgical wounds, and those with indwelling catheters.Pseudohyphae are formed by a wide variety of yeast species including most pathogenic candida species and many pleiomorphic fungi that exhibit transitions between filamentous and unicellular forms of growth.(veses & gow, 2009) per internal technical review, 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.Citation: bacillus species - infectious disease and antimicrobial agents.(n.D.).Retrieved april 14, 2023, from http://www.Antimicrobe.Org/b82.Asp bottone, e.J.(2010).Bacillus cereus, a volatile human pathogen.In clinical microbiology reviews (vol.23, issue 2, pp.382¿398).Https://doi.Org/10.1128/cmr.00073-09 veses, v., & gow, n.A.R.(2009).Pseudohypha budding patterns of candida albicans.Medical mycology, 47(3), 268¿275.Https://doi.Org/10.1080/13693780802245474 investigation is in process.A follow up report will be provided.

Event Description

The customer reported that the trima set was found to have a leak at the 3-way joint.The customer sent the platelet bag into the system for testing.On (b)(6) 2023, this platelet bag passed the test and then the hospital used it with a patient.After patient received the platelets, the patient developed chills.The doctor sent the platelet bag for testing again, and the test resulted with bacillus cereus and pseudohyphae was found in the gram stain.The patient was tested, and at 11 hrs, the culture result showed positive for gram-positive bacilli.The customer confirmed that that they don¿t know what the medical intervention was given to the recipient.Patient weight is not available.The platelet set is not available for return for evaluation.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLT SAMPLER AUTOPAS MULTIPLS
• 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: 16469460
• MDR Text Key: 310547600
• Report Number: 1722028-2023-00087
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: 80310
• Device Lot Number: 2203221230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2022
• 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
• Patient Age: 30 YR
• Patient Sex: Female