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AEROGEN LTD AEROGEN SOLO NEBULISER SYSTEM *HOSPITAL ONLYNEONATE, PEDIATRIC AND ADULT PATIENT; AEROGEN SOLO NEBULIZER SYSTEM
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| Model Number AG-AS3001 |
| Device Problems
Use of Device Problem (1670); Insufficient Information (3190)
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| Patient Problem
Low Oxygen Saturation (2477)
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| Event Date 07/21/2023 |
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Event Type
Injury
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Manufacturer Narrative
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Aerogen have taken the appropriate measures to review and investigate the complaint received.Aerogen have requested further information from the reporting healthcare worker to determine further details on the event and had requested the return of the device.A review per aerogen's 'field correction / removal procedure' was completed based on this complaint received which may pose a risk to patients.Based on the nature of the complaint, and current investigation in progress it has been concluded that no field correction or removal is required by aerogen at this time.This will be reviewed as investigation progresses and if any further information becomes available to aerogen which may impact the previous no fsca determination, the review and conclusion will be documented within the subsequent report.
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Event Description
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Hospital reported the following: 'air leak on the ventilator causing the patient to desaturate and not ventilate appropriately.The leak caused 90mls difference between the inspiratory and expiratory volumes.Biomedical engineers / doctors and nurses troubleshot the ventilator at the time and the ventilator pre use check was fine.The issue in ventilating was put down to a leak in the aerogen.This is from our biomedical engineers if it helps "from the logs, i could see that the ventilator successfully passed the pre-use check and patient circuit test last night before being connected to the patient.Most likely, the leak occurred when the nebulizer was connected after the patient had already been ventilated.This led to a significant difference of approximately 90 ml between vti and vte during patient ventilation." vent model - servou, vent mode - prvc, position - dry side of humidification, not on anesthetic medications, nebulising salbutamol and ipratropium.Troubleshooting: patient swapped to new ventilator and circuit (aerogen not connected) - nil further air leak.Biomed engineer - troubleshooted air leaking circuit when patient not on ventilator.Removed aerogen solo and t-piece no leak, when in dry side of humidification air leak noted.Repeated process a couple of times with air leak continuing.Visual inspection of t-piece no obvious cracks.' aerogens customer complaints team are currently investigating.
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Event Description
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Hospital reported the following: 'air leak on the ventilator causing the patient to desaturate and not ventilate appropriately.The leak caused 90mls difference between the inspiratory and expiratory volumes.Biomedical engineers / doctors and nurses troubleshot the ventilator at the time and the ventilator pre use check was fine.The issue in ventilating was put down to a leak in the aerogen.This is from our biomedical engineers if it helps "from the logs, i could see that the ventilator successfully passed the pre-use check and patient circuit test last night before being connected to the patient.Most likely, the leak occurred when the nebulizer was connected after the patient had already been ventilated.This led to a significant difference of approximately 90 ml between vti and vte during patient ventilation." vent model: servou, vent mode: prvc, position: dry side of humidification, not on anesthetic medications, nebulising salbutamol and ipratropium troubleshooting: patient swapped to new ventilator and circuit (aerogen not connected) nil further air leak.Biomed engineer - troubleshooted air leaking circuit when patient not on ventilator.Removed aerogen solo and t-piece no leak, when in dry side of humidification air leak noted.Repeated process a couple of times with air leak continuing.Visual inspection of t-piece no obvious cracks.' aerogens customer complaints team are currently investigating.
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Manufacturer Narrative
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Aerogen have taken the appropriate measures to review and investigate the complaint received.Aerogen have requested further information from the reporting healthcare worker to determine further details on the event and had requested the return of the device.A review per aerogen's 'field correction/removal procedure' was completed based on this complaint received which may pose a risk to patients.Based on the the nature of the complaint, and current investigation in progress it has been concluded that no field correction or removal is required by aerogen at this time.This will be reviewed as investigation progresses and if any further information becomes available to aerogen which may impact the previous no fsca determination, the review and conclusion will be documented within the subsequent report.Update on the 23rd of october: follow up report 1 submitted for the additional information of investigation conclusions completed.The report has been updated for the following fields only b4, d9, g6,g7,h2,h6,h8 and h10 and narrative below: risk assessment: the nebuliser involved in the reported complaint has not been returned to aerogen and has been discarded, therefore a root cause has not been successfully determined.In aerogens risk documentation, there are 2 instances of hazards which lead to the harm of "no or reduced supplemental oxygen" which both take into account a number of design controls which mitigate the harm.A leak in the breathing circuit after nebulizer is inserted or removed can be attributed to potential reasonably foreseeable misuse.Prior to use, the dfu states that the user should always perform a leak test of the breathing circuit after inserting or removing the nebulizer unit as per ventilator manufacturer instructions.However, as per the information provided in the follow up discussions with the hospital, the pre-use check carried out by the biomedical engineer was successful.A potential hazard as per the dffmeca is "ventilator leakage through nebulizer" which has a potential cause of poor fit between the t-piece and nebulizer, leakage through the ap causing ventilator alarms.A design control is in place to mitigate this.The dfu also warns the user to observe for correct functioning of the nebulizer during use.This risk carries an overall low risk to the end user, which is deemed acceptable.The risk documentation also led to another potential cause for the issue, incorrect assembly of the system, with potential causes listed as inadequate labelling - incorrect or misleading instructions or illustrations in the dfu resulting in medication leakage.This can also be attributed to reasonably foreseeable misuse.As per the dfu, the dfu instructs the user on correct system assembly.As the unit was not returned to aerogen for further investigation, a conclusion on the alleged malfunction cannot be made, and a root-cause cannot be determined.Clinical assessment an air leak was noted on a ventilator that reportedly led to patient desaturation (76%).A leak in the ventilator circuit after the nebuliser is inserted or removed can be attributed to potential reasonably foreseeable misuse as per the risk assessment above.Based on the information specified, it is possible that an apparent leak in the ventilator circuit may have contributed to the patient impact observed.A leak in the ventilator circuit after the nebuliser is inserted or removed may be attributed to reasonably foreseeable misuse.As no device was returned for examination it is not possible to confirm its role, if any, in the reported incident.It should be noted, that the patient was being treated for airway burns and periods of desaturation were noted both when the aerogen device was in place and also after the device was removed conclusion: it was noted, that the patient was being treated for airway burns and periods of desaturation were noted both when the aerogen device was in place and also after the device was removed.The nebuliser involved in the reported complaint has not been returned to aerogen and has been discarded, therefore a root cause has not been successfully determined and it is not possible to confirm its role, if any, in the reported incident.
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Manufacturer Narrative
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Aerogen have taken the appropriate measures to review and investigate the complaint received.Aerogen have requested further information from the reporting healthcare worker to determine further details on the event and had requested the return of the device.A review per aerogen's 'field correction/removal procedure' was completed based on this complaint received which may pose a risk to patients.Based on the nature of the complaint, and current investigation in progress it has been concluded that no field correction or removal is required by aerogen at this time.This will be reviewed as investigation progresses and if any further information becomes available to aerogen which may impact the previous no fsca determination, the review and conclusion will be documented within the subsequent report.Update on the 23rd of october: follow up report 1 submitted for the additional information of investigation conclusions completed.The report has been updated for the following fields only b4, d9, g6,g7,h2,h6,h8 and h10 and narrative below: risk assessment: the nebuliser involved in the reported complaint has not been returned to aerogen and has been discarded, therefore a root cause has not been successfully determined.In aerogens risk documentation, there are 2 instances of hazards which lead to the harm of "no or reduced supplemental oxygen" which both take into account a number of design controls which mitigate the harm.A leak in the breathing circuit after nebulizer is inserted or removed can be attributed to potential reasonably foreseeable misuse.Prior to use, the dfu states that the user should always perform a leak test of the breathing circuit after inserting or removing the nebulizer unit as per ventilator manufacturer instructions.However, as per the information provided in the follow up discussions with the hospital, the pre-use check carried out by the biomedical engineer was successful.A potential hazard as per the dffmeca is "ventilator leakage through nebulizer" which has a potential cause of poor fit between the t-piece and nebulizer, leakage through the ap causing ventilator alarms.A design control is in place to mitigate this.The dfu also warns the user to observe for correct functioning of the nebulizer during use.This risk carries an overall low risk to the end user, which is deemed acceptable.The risk documentation also led to another potential cause for the issue, incorrect assembly of the system, with potential causes listed as inadequate labelling - incorrect or misleading instructions or illustrations in the dfu resulting in medication leakage.This can also be attributed to reasonably foreseeable misuse.As per the dfu, the dfu instructs the user on correct system assembly.As the unit was not returned to aerogen for further investigation, a conclusion on the alleged malfunction cannot be made, and a root-cause cannot be determined.Clinical assessment: an air leak was noted on a ventilator that reportedly led to patient desaturation (76%).A leak in the ventilator circuit after the nebuliser is inserted or removed can be attributed to potential reasonably foreseeable misuse as per the risk assessment above.Based on the information specified, it is possible that an apparent leak in the ventilator circuit may have contributed to the patient impact observed.A leak in the ventilator circuit after the nebuliser is inserted or removed may be attributed to reasonably foreseeable misuse.As no device was returned for examination it is not possible to confirm its role, if any, in the reported incident.It should be noted, that the patient was being treated for airway burns and periods of desaturation were noted both when the aerogen device was in place and also after the device was removed conclusion: it was noted, that the patient was being treated for airway burns and periods of desaturation were noted both when the aerogen device was in place and also after the device was removed.The nebuliser involved in the reported complaint has not been returned to aerogen and has been discarded, therefore a root cause has not been successfully determined and it is not possible to confirm its role, if any, in the reported incident.Update on the 12th of january: follow up report 2 submitted for the addition of 510k number.The report has been updated for the following fields, b4,g4, g6,h2.
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Event Description
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Hospital reported the following: 'air leak on the ventilator causing the patient to desaturate and not ventilate appropriately.The leak caused 90mls difference between the inspiratory and expiratory volumes.Biomedical engineers / doctors and nurses troubleshot the ventilator at the time and the ventilator pre use check was fine.The issue in ventilating was put down to a leak in the aerogen.This is from our biomedical engineers if it helps "from the logs, i could see that the ventilator successfully passed the pre-use check and patient circuit test last night before being connected to the patient.Most likely, the leak occurred when the nebulizer was connected after the patient had already been ventilated.This led to a significant difference of approximately 90 ml between vti and vte during patient ventilation." vent model - servou, vent mode - prvc, position - dry side of humidification, not on anesthetic medications, nebulising salbutamol and ipratropium troubleshooting: patient swapped to new ventilator and circuit (aerogen not connected) - nil further air leak.Biomed engineer - troubleshooted air leaking circuit when patient not on ventilator.Removed aerogen solo and t-piece no leak, when in dry side of humidification air leak noted.Repeated process a couple of times with air leak continuing.Visual inspection of t-piece no obvious cracks.' aerogens customer complaints team are currently investigating.
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