MAUDE Adverse Event Report: AEROGEN LTD AEROGEN SOLO NEBULIZER SYSTEM

Model Number AG-AS3001

Device Problem Use of Device Problem (1670)

Patient Problems Aspiration/Inhalation (1725); Unintended Extubation (4564); Insufficient Information (4580)

Event Date 06/19/2023

Event Type  Injury  

Manufacturer Narrative

Aerogen have taken the appropriate measures to review and investigate the complaint received.Aerogen have requested return of the device from the reporting healthcare worker.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.Please note that aerogen solo use with tracheostomy is not an approved intended use in the us as per current 510k clearance and associated device manuals and labelling.Aerogen solo is approved for use with tracheostomy in the uk in which the event occured.This event is submitted to the us as the aerogen solo in scope of the event is cleared in the us, however the intended use in scope of this event is not cleared in the us.

Event Description

The patient is a long term ventilated patient via a tracheostomy on a resmed ventilator.The nursing team reported that 3 separate solos failed to deliver the 0.9% saline nebuliser dose to the patient resulting in a build up of patient secretions leading to 2 emergency tracheostomy tube changes.There were also 2 separate incidences of increased resistance in the tracheostomy reported due to solo stoppage and non-delivery of prescribed nebulised 0.9% saline.Aerogens customer complaints team are currently investigating.

Manufacturer Narrative

Aerogen have taken the appropriate measures to review and investigate the complaint received.Aerogen have requested return of the device from the reporting healthcare worker.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.Please note that aerogen solo use with tracheostomy is not an approved intended use in the us as per current 510k clearance and associated device manuals and labelling.Aerogen solo is approved for use with tracheostomy in the uk in which the event occurred.This event is submitted to the us as the aerogen solo in scope of the event is cleared in the us, however the intended use in scope of this event is not cleared in the us.Update on 12th september 2023: follow up report is submitted for the additional information of investigation conclusions completed.The report has been updated for the following fields only and the narrative below: b4, d9, g6, h2, h3 & h6.Aerogen have taken the appropriate measures to review and investigate the complaint received including the following: aerogen requested the device be returned for investigation.The returned device was investigated and passed testing with no functional fault found.Risk assessment has been completed to summarize the risk analysis conducted as per aerogens risk management procedures and en iso 14971.There are a number of design and information controls provided to the user in the event of nebuliser stoppage, to prevent this failure mode from occurring.The most likely outcome of this based on review of risk documentationis is "no or incomplete or prolonged drug delivery", which is an anticipated risk identified by aerogen for devices and has been appraised as part of aerogens risk management procedure.The complaint rate for this particular issue results in a "improbable" occurrence (> 0.001 - 0.01%).No further action is required based on this risk assessment completed as per aerogen's risk management procedures and en iso14971 "application of risk management for medical devices".Based on the information received, there will be no new protective measures introduced or no new risks or additional harms being introduced because of this assessment.In addition, a review was completed per aerogen's field correction/removal procedure', based on this complaint received.Based on the risk assessment completed above, aerogen concluded that the completion of a product assessment form is not warranted at this time due to the nature of the complaint.It has been concluded that no field correction or removal is required by aerogen at this time because of this assessment.Clinical assessment has been completed for review of the event and clinical determination of potential to attribute to serious incident.Firstly, it is clear that ns nebulisation is an accepted clinical adjunct therapy in tracheostomized patients.It is also clear that this therapy has little to no data to support its efficacy as a method of humidification or for secretion management.Secondly, available guidance clearly establishes that the management of a tracheostomized patient's humidification, systemic hydration, and secretion management are central in the prevention of tt occlusion.Therefore, with regard to this specific incident in which build-up of secretions/ occlusions have occurred, it is most likely that the root cause relates to deficiencies in one (or more) of these core pillars.Finally, it cannot be discounted that available aerosol science literature suggests the device placement at the dry side of the humidifier prior to an intentional leak port, is likely to have severely impacted the delivery of the nebulised ns to these patients.Despite the lack of clear efficacy data to support ns nebulisation as a method of humidification it cannot be definitively determined that this did not contribute to the inspissation of patient secretions and tt occlusion.The incident has been categorised by aerogen as a reportable incident with no known device problem identified with the device in the scope as the device passed testing with no functional fault found.Therefore based on the assessments completed to date there are no further actions determined by aerogen at this time and aerogen will continue to monitor complaints received, the occurrance rating and severity of the risk as per aerogens quality management system.

Event Description

The patient is a long term ventilated patient via a tracheostomy on a resmed ventilator.The nursing team reported that 3 separate solos failed to deliver the 0.9% saline nebuliser dose to the patient resulting in a build up of patient secretions leading to 2 emergency tracheostomy tube changes.There were also 2 separate incidences of increased resistance in the tracheostomy reported due to solo stoppage and non-delivery of prescribed nebulised 0.9% saline.Aerogens customer complaints team are currently investigating.

Event Description

The patient is a long term ventilated patient via a tracheostomy on a resmed ventilator.The nursing team reported that 3 separate solos failed to deliver the 0.9% saline nebuliser dose to the patient resulting in a build up of patient secretions leading to 2 emergency tracheostomy tube changes.There were also 2 separate incidences of increased resistance in the tracheostomy reported due to solo stoppage and non-delivery of prescribed nebulised 0.9% saline.Aerogens customer complaints team are currently investigating.

Manufacturer Narrative

Aerogen have taken the appropriate measures to review and investigate the complaint received.Aerogen have requested return of the device from the reporting healthcare worker.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.Please note that aerogen solo use with tracheostomy is not an approved intended use in the us as per current 510k clearance and associated device manuals and labelling.Aerogen solo is approved for use with tracheostomy in the uk in which the event occurred.This event is submitted to the us as the aerogen solo in scope of the event is cleared in the us, however the intended use in scope of this event is not cleared in the us.Update on 12th september 2023: follow up report is submitted for the additional information of investigation conclusions completed.The report has been updated for aerogen have taken the appropriate measures to review and investigate the complaint received including the following: aerogen requested the device be returned for investigation.The returned device was investigated and passed testing with no functional fault found.Risk assessment has been completed to summarize the risk analysis conducted as per aerogens risk management procedures and en iso 14971.There are a number of design and information controls provided to the user in the event of nebuliser stoppage, to prevent this failure mode from occurring.The most likely outcome of this based on review of risk documentationis is "no or incomplete or prolonged drug delivery", which is an anticipated risk identified by aerogen for devices and has been appraised as part of aerogens risk management procedure.The complaint rate for this particular issue results in a "improbable" occurrence (> (b)(4) %).No further action is required based on this risk assessment completed as per aerogen's risk management procedures and en iso14971 "application of risk management for medical devices".Based on the information received, there will be no new protective measures introduced or no new risks or additional harms being introduced because of this assessment.In addition, a review was completed per aerogen's field correction/removal procedure', based on this complaint received.Based on the risk assessment completed above, aerogen concluded that the completion of a product assessment form is not warranted at this time due to the nature of the complaint.It has been concluded that no field correction or removal is required by aerogen at this time because of this assessment.Clinical assessment has been completed for review of the event and clinical determination of potential to attribute to serious incident.Firstly, it is clear that ns nebulisation is an accepted clinical adjunct therapy in tracheostomized patients.It is also clear that this therapy has little to no data to support its efficacy as a method of humidification or for secretion management.Secondly, available guidance clearly establishes that the management of a tracheostomized patient's humidification, systemic hydration, and secretion management are central in the prevention of tt occlusion.Therefore, with regard to this specific incident in which build-up of secretions/ occlusions have occurred, it is most likely that the root cause relates to deficiencies in one (or more) of these core pillars.Finally, it cannot be discounted that available aerosol science literature suggests the device placement at the dry side of the humidifier prior to an intentional leak port, is likely to have severely impacted the delivery of the nebulised ns to these patients.Despite the lack of clear efficacy data to support ns nebulisation as a method of humidification it cannot be definitively determined that this did not contribute to the inspissation of patient secretions and tt occlusion.The incident has been categorised by aerogen as a reportable incident with no known device problem identified with the device in the scope as the device passed testing with no functional fault found.Therefore based on the assessments completed to date there are no further actions determined by aerogen at this time and aerogen will continue to monitor complaints received, the occurrance rating and severity of the risk as per aerogens quality management system.Update on the 12th of january: follow up report 2 submitted for the addition of 510k number.

• Brand Name: AEROGEN SOLO NEBULIZER SYSTEM
• Type of Device: AEROGEN SOLO
• Manufacturer (Section D): AEROGEN LTD; galway business park; dangan; galway, H91EH 6C; EI H91EH6C
• Manufacturer (Section G): AEROGEN LTD; galway business park; dangan; galway, H91EH 6C; EI H91EH6C
• Manufacturer Contact: andrea small ; galway business park; dangan; galway, H91EH-6C ; EI H91EH6C
• MDR Report Key: 17315573
• MDR Text Key: 319037848
• Report Number: 3003399703-2023-21746
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K070642
• 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
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AG-AS3001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other