|
Intended use: bact/alert® pf plus culture bottles are used with bact/alert® microbial detection systems in qualitative procedures for recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.Description of the issue: a customer in australia notified biomérieux of obtaining a potential bottle contamination with aspergillis fumigatis when using the bact/alert pf plus (plastic) - reference (b)(4) ( lot#0004101258- expiration date : 16 sept 2023).There is no indication or report from the customer that this event led to or contributed to any death, serious injury, or serious deterioration in the state of health for the concerned patient.This customer has also reported the same issue with the bact/alert fa plus (plastic) - 410851 ( lot#0004100912) which is documented in the complaint (b)(4).This event has been reviewed for vigilance reporting in accordance with 21 cfr 803, concerning medical device reporting.Per biomérieux bmx.1.018481 - bactalert microbial detection system hazard definition document, false positive result in association with bact/alert® fa plus culture bottles is considered to be a potentially reportable event (pre).A false positive result could have a negative influence on the medical diagnosis and potentially on the treatment (e.G.Unnecessary antibiotics, unnecessary diagnostic tests).Mitigated by the fact that other diagnostic information, including clinical findings and laboratory results, are likely available to aid in the medical diagnosis.This review has determined that this event meets the criteria for reporting as a malfunction.Although this event does not allege that death or serious injury actually occurred, it has been determined that there is potential for serious injury should the situation recur while testing a patient isolate.A biomérieux internal investigation will be initiated.
|
|
Context: an investigation was initiated in response to one customer¿s complaint relating to inoculated blood culture bottle contamination.The customer reported that they had growth of aspergillus fumigatus in pf plus lot 0004101258 (expiry date 16sep2023).No impact to patients, since the customer considered this organism as a contaminant.This organism is a filamentous fungi found in the environment.Investigation results: summary of manufacturing processes for bact/alert products related to contamination issue; manufacturing directions for bact/alert culture bottles have two process points where bottles are exposed to a high temperature (> 120°c) for a required time period in efforts to reduce the possibility of contaminated units.Exposure of the bottles to the time and temperature of these two process points is sufficient to kill most non-spore forming organisms.In addition, a contamination check on the bottles is conducted by taking a sampling of bottles, prior to the autoclave process (after the bottles have been filled, degassed, stoppered, and capped) and submitted to quality control for bioburden testing.Bioburden determines the number of microbial organisms found in a given amount of material associated with contamination introduced from possible sources (e.G., raw materials, personnel, equipment or cleanliness of the production environment).The bioburden testing of bact/alert production lots aids in the monitoring of any adverse fluctuation that can potentially occur between lots.Bioburden results must pass specifications prior to release of the bact/alert product for use.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.One of the monitoring and methods takes place with the unique device identifier (udi) packaging line with 100% inspection of bottles by an automated vision system (e.G., cameras) that aid in the detection of bottle defects including the defects associated with potential contamination (e.G., yellow color of the les sensor on the bottom of the bottles).Manual inspections are also performed during the packaging acceptance quality limit (aql) and final aql visual inspections.A sampling of bottles is inspected as per an aql which is a maximum number of defective units that can be considered acceptable as a process average.The customer did not report any bottle defects prior to loading the bottles into the virtuo instrument.Inoculation of samples into the bact/alert pf plus bottles by the user contributed to this complaint issue.Therefore, batch reviews were not required for this investigation.All statistical in process controls were monitored and aql inspections were performed for the lot as part of routine batch records.All quality control specifications passed for release of the pf plus products to customers.Retained lot: retains: pf plus lot 0004101258: there were 300 retain samples inspected from lot 0004101258 (expiry date 16sep2023) on 18jul2023 by a gcs investigator.No cloudy bottles (turbid media), or bottles with yellow sensors were found.If found, yellow sensor or cloudy media would potentially indicate the bottles were contaminated before use.No other visual defects were evident that would indicate any contamination of these pf plus retain bottles.Root cause analysis: the fishbone diagram (¿5m+e¿) method of analysis was used to investigate and identify the potential root cause/root cause for this complaint.This cause-and-effect analysis identifies aspects of the issue in relation to following conditions: measurement, materials, method, machine, manpower, and environment.The investigator reviewed manufacturing processes for bact/alert culture bottles that address the potential contamination of bottles during production, as well as communication between customer service and the customer pertaining to the complaint issue.The root cause assessment showed that the manufacturing processes are captured in procedural directions on a routine basis and results of these directions are documented as part of good manufacturing practices.Monitoring and detection methods relating to potential bottle contamination are appropriately in place at the durham manufacturing site.The packaging aql inspection record and the final aql visual inspection summary and disposition record are in place to identify defects relating to potential contamination associated with manufacturing processes of bact/alert culture bottles.The ifu for the bact/alert pf plus provide adequate guidance on how to reduce contamination during sample collection/bottle inoculation.Manufacturing equipment is maintained for operation and procedures are in place to conduct production processes.Environmental monitoring occurs on a routine basis in the manufacturing facility for bact/alert culture bottles.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 pf plus with a.Fumigatus pertaining : materials, manpower and environment are the potential contributing factors to the root cause of this complaint.Complaint analysis: a complaint search has been performed and did not indicate any systematic quality issue production record: no non conformities nor deviation were written for performance issues related to the issue under investigation.Conclusion: the investigation did not indicate any evidence of product malfunction.The bact/alert pf plus detected organism growth as intended; however, the organism detected was a.Fumigatus and a suspected contaminant as per the customer.The one pf plus bottle graph flagged positive at approximately 1.6 days, which is consistent with the organism entering the bottle with the sample.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 a.Fumigatus has been shown at 25°c to above 37°c.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.A.Fumigatus does form spores, but these spores are not known to be heat resistant to be able to survive an autoclave cycle.Information for use provide adequate direction to prevent specimen contamination during collection/inoculation into the bact/alert bottles: proper skin disinfection is an essential requirement to reduce the incidence of contamination.Prior to inoculation, disinfect the culture bottle top with an alcohol swab or equivalent.Allow to dry.Gcs advises to use one disinfectant prep per bottle top to prevent picking up spores from one bottle top and depositing them on another.The mechanical wiping action is how spores are removed from the stopper surface.Prevent contamination of the patient sample during venipuncture and during inoculation into the culture bottles.Contamination could lead to a specimen being determined positive when a clinically relevant isolate is not actually present.Culture bottle contamination may not be readily apparent.Monitor the direct draw process closely to avoid reflux.
|
