|
Context: a customer in the united states notified biomérieux of obtaining a potential bottle contamination with paecilomyces variotii when using the bact/alert fa plus (plastic) - (b)(4), (lot# 004101558- expiration date : 2/15/2024).The customer reported that they had growth of a mold, paeciliomyces variotii, in three (3) bact/alert® fa plus bottle types with two lot numbers 0004101610 and 004101558.The number of patients was unknown.The organism was identified by the maldi-tof (mass spectrometry) for two bottles, and the third bottle was also sent out to a reference laboratory for identification.This organism is a filamentous spore forming fungi found in the environment and can be a causative agent of opportunistic mycoses in immunocompromised hosts.This was thought to be an unusual isolate in three blood culture bottles, so the results were questioned if they could be contaminants.The bottles were tested on the bact/alert® virtuo® system with a unit serial number (b)(6) software version virtuo 03.01.01.1274 installed 14sep2021.The time to positive for the three bottles was not shared.Investigation: *************** ** batch history record and complaint trend analysis** there is no capa related to the customer¿s complaint recorded.A complaint history review was completed for this issue concluded with no implication of a trend.This complaint has not been identified as a systemic quality issue.**investigation results** root cause analysis: based on the evaluation of data and the information provided by the customer, there are three most probable root causes for contamination source of bact/alert fa plus bottles with p.Variotii pertaining to complaint inv (b)(4) materials, manpower and environment are the potential contributing factors to the root cause of this complaint.The customer suspected contamination of culture bottles with paecilomyces variotii (p.Variotii) when using two lots of fa plus bottles (lot 0004101610 and lot 0004101558).Three bottles (at least one bottle from each lot) were sent to the same laboratory for organism identification, p.Variotii.Article: identification of paecilomyces variotii in clinical samples and settings; j.Houbraken, p.E.Verweij, a.J.M.M rijs, a.M.Borman, and r.A.Samson; journal of clinical microbiology, aug.2010, p.2754-2761; doi:10.1128/jcm.00764-10.Key points of this article that are associated with this investigation are listed below: ¿ paecilomyces variotii (p.Variotii) is an organism that has been found in pasteurized foods, soil, indoor air, and wood ¿ it has also been associated with human infections in immunocompromised patients, especially skin or catheter related ¿ isolates of p.Variotii have been found cerebrospinal fluid, feces, mouthwash, elevator shaft, abcess, eye tumor, sputum, heat-processed fruit drink, and unknown sources ¿ p.Variotii thrives at high temperatures (thermophilic) and grows best at 25°c and 37°c ¿ presence of p.Variotii found in clinical samples related to food and indoor environment sources ¿ this organism can grow in extreme conditions (e.G., very hot, dry, very low micronutrients) signs of bottle contamination would be detected by visual appearances of the bottles (e.G., turbidity of media, yellow sensors) and/or rejected by detection methods during manufacturing processes.In addition, bact/alert bottles are exposed to high temperatures, above the survival temperature of p.Variotii, at different stages during the production process (e.G., p.Variotii spores can survive around 80°c for 15 minutes, see section for environment, below).The customer did not confirm the sample types from patient(s) (e.G., blood or body fluids) or the method of sample collection (e.G., venipuncture, syringe, or catheter).However, it is possible that the bottles and any of the common devices used for sample collection (e.G., disinfectant wipe packets, syringe packs, butterfly packets) could have originated from the same dry storage location within the same hospital where the bottle were inoculated.P.Variotii, having thermophilic and spore forming characteristics, could have easily dispersed onto outside packaging of sample collection components.A point of entry into the patient¿s blood culture sample in a fa plus bottle as a contaminant would be through a physical contact of a blood drawing device or another device used on the patient with presence of the viable organism.Materials are a potential contributing factor to this complaint.P.Variotii is a spore forming organism and can adhere to surfaces in a dormant stage for a prolonged period of time.These spores can disperse easily though air and can be transported to culture bottles through contact with a patient¿s bedding if bottles are close to/on the bedding.Spores can be transported through the contact with staff/patient clothes.Since the most common way for a contaminant to be introduced into the bottle is during the sample collection process and/or inoculation into the bact/alert culture bottles, it is important to conduct proper disinfection of bottle top(s) and intended site of the venipuncture on the patient¿s skin.A mechanical swiping of the bottle top with a disinfectant pad (one per bottle) will aid in the removal of spores.Staff should avoid contact of surfaces after gloves are on and prior to inoculation of sample into the bottle (e.G., bedding, computer keyboards, cell phones, curtains, portable drawing station holding supplies).The customer reported that they were conducting an internal investigation concerning the presence of p.Variotii , a mold) in the fa plus culture bottles.The presence of p.Variotii in the fa plus bottles was considered suspect, most likely the patient(s) did not exhibit any health conditions associated with p.Variotii.The customer did not communicate any specific information on which technique (venipuncture or syringe draw) was used to inoculate fa plus culture bottles.Venipuncture is widely recommended method for blood collection.Blood collection from an intravenous catheter is subjected to a higher risk of contamination and adequate collection of blood volume in the bottles aids in the detection of microorganisms attributed to blood infections.Manpower is a potential contributing factor to this complaint.Environmental conditions such as dust, dirt, light, temperature, biological material, and humidity conditions at a clinical facility are contributing factors to sample contamination, if exposed to one or a combination of these conditions.Monitoring and detection methods are inherent to manufacturing processes to identify any potential contamination of the culture bottles as a result of the bact/alert culture bottle production.Optimal growth of p.Variotii has been shown at 25°c to above 37°c.However, spores can survive around 80°c for 15 minutes (see article below).Manufacturing processes for bact/alert culture bottles expose the bottles to higher temperatures than the survival temperature of this organism.There is no indication that the contaminants originated from the manufacturing facility.Article 1: biocontrol effects of paecilomyces variotii against fungal plant diseases; a.Moreno-gavira, f.Dianez, b.Sanchez-montesinos and m.Santos; j.Fungi 2021,7,415.Https://doi.Org/10.3390/jof7060415.Key points of this article that are associated with this investigation are listed below: ¿ study focus was on the application of paecilomyces variotii (p.Variotii) on several different crops (e.G., melon, zucchini, pepper, tomato) to see the control of pests and diseases ¿ this organism can survive high temperatures (thermophilic), grows rapidly, can grow in oxygen-limited conditions, widespread adaptability ¿ p.Variotii produces spores that can survive above 80°c for 15 minutes ¿ it has been found in many habitats (e.G., air, water, plant debris, inside plants (soil), animals (potentially contaminating food), homes, operating rooms) ¿ p.Variotii can be used as a plant growth promoter and controls fungal plant diseases article 2: characterization and outcome of invasive infections due to paecilomyces variotii: analysis of patients from the fungiscope® registry and literature reports; r.Spute, j.Salmanton-garcia, e.Sal, x.Malaj, i.Falces-romero, l.Hatvani, m.Heinemann, n.Klimko, l.Lopez-soria, j.Meletiadis, m.Shruti, j.Steinmann, d.Seidel, o.A.Cornely, and j.Stemler; j antimicrob cheother 2021; 76:765-774; doi:10.1093/jac/dkaa481.Key points of this article that are associated with this investigation are listed below: ¿ this literature/fungiscope® registry study identified 59 cases of p.Variotii infection and found the highest presence of this organism in indwelling devices (peritoneal catheters (for draining of abdomen cavity) and prosthetic heart valves) ¿ cases were reported from 22 countries with the highest number from the united states followed by australia and india ¿ p.Variotii has been identified in immunocompromised and immunocompetent patients ¿ paecilomyces species are thermos-tolerant fungi that are found widespread in soil, decomposing organic material, food product, and house dust ¿ p.Variotii infections are rare but can be associated with blood stream, central nervous system (cns), peritonitis (abdomen), skin/soft tissue, eye the clinical customer, erlanger medical center, belongs to the erlanger health system.The health system provides academic teaching in affiliation with the university of tennessee college of medicine, chattanooga.There are five adult hospitals and one pediatric hospital which provides inpatient and outpatient care (e.G., through the emergency department) to the tri-state region of tennessee, usa.The fa plus bottles were inoculated with patient samples from one of the hospitals in the system and sent for laboratory testing.The customer did not specify the location of the hospital the patient(s) were drawn.If any of the patients were drawn in the emergency department, it would be one of the high traffic areas most exposed to external elements brought in with patients and the potential for blood culture bottle contamination would be high.P.Variotii can be found in the environment, found mainly in soil, air, and plants.Studies have shown this organism is associated with hospital environments, both inside and outside.Migration of p.Variotii spores can occur by way of staff/patient clothing and/or construction/renovation of hospital areas (e.G., near storage areas for hospital supplies).Use of appropriate disinfectants on hospital setting surfaces, hand washing by staff, wearing gloves by staff, limited contact with hospital surfaces with gloves prior to specimen collection with bact/alert bottles will reduce the presence of contaminating organisms (e.G., p.Variotii) environment is a potential contributing factor to this complaint.Retains: fa plus lot 0004101610: there were 300 retain samples inspected from lot 0004101610 (expiry date 08mar2024) on 19jul2023 by a gcs investigator.No visual defects related to potential contamination were observed for these bottles.Fa plus lot 0004101558: there were (b)(4) retain samples inspected from lot 0004101558 (expiry date 15feb2024) on 19jul2023 by a gcs investigator.No visual defects were found related to potential contamination of these bottles.Returned products and testing: no requirement for returned bottles that were inoculated with patient samples.Conclusion: ************* conclude product compliance to specification/performance: there is no evidence of any bottle malfunction with the bact/alert fa plus culture bottle lots.The bact/alert fa plus bottles detected organism growth as intended; however, the organism detected was p.Variotii and a suspected contaminant as per the customer.Monitoring and detection methods for potential bottle contamination are part of the manufacturing and quality control processes for bact/alert culture bottles prior to the release of product to customers.The optimal growth of p.Variotii, a mold, has been shown at 25°c to above 37°c.However, a study has shown that this mold can survive at least 80°c for 15 minutes.Manufacturing processes for bact/alert culture bottles expose the bottles to higher temperatures than the survival temperature of this organism.There is no indication that the contaminants originated from the manufacturing facility.P.Variotii does form spores, but these spores are not known to be heat resistant to be able to survive an autoclave cycle.
|
