| Model Number AG-AS3001 |
| Device Problems
Use of Device Problem (1670); Malposition of Device (2616)
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| Patient Problems
Aspiration/Inhalation (1725); Unintended Extubation (4564); Insufficient Information (4580)
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Event Type
Injury
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Event Description
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On 15th december 2021 aerogen were notified of 2 potential serious incidents from (b)(6), related to paediatric patients in the paediatric intensive care unit (picu) with use of the aerogen solo nebuliser and tracheotomy placement.This mdr is for the 2nd potential serious incident, (aerogen reference (b)(4)).The complaint outlined that the healthcare providers in the picu followed the aerogen set up guide in which nebulisers were not delivered properly, which resulted in emergency situations with children blocking off tracheotomy tubes and requiring emergency changes.The reporter stated the following on use of the aerogen set up guide 'the guide demonstrates photos and states the use of the nebuliser attached to the inlet chamber of the humidifier, however, nowhere does it state this is only for use on dual limb circuits or airvo's.Nowhere does it state for use on single limb circuits with exhalation valves.The aerosol leaks out of the exhalation port when the nebuliser is placed anywhere in the circuit below the exhalation port and therefore medication is not delivered to the detriment of the patient.After discussion with the rep, we have established in these ventilation circuits, such as breas and astral, the nebuliser must be situated above the exhalation valve.Also, in the quick reference guide nowhere does it state the solo 28 day change of the nebuliser and t piece is based on intermittent use of less than 4 times per day.As a consequence, staff have used it more frequently for 0.9% sodium chloride nebulisers and this had crystalised the mesh, stopping the solo working.This has again led to a nebuliser not getting delivered (1st potential serious incident not in scope of this mdr, aerogen reference (b)(4) ) and a separate child requiring an emergency tracheotomy change following blocking off.' (2nd potential serious incident in scope of this mdr, aerogen reference (b)(4) ).On follow up, the aerogen clinical support specialist received information that the patient required an emergency tracheostomy tube change.This would mean that the patient was struggling to breathe.Clarification on number of tube changes not yet confirmed.
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Manufacturer Narrative
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The complaint referred to 2 potential serious incidents and aerogen have separated into two complaint files and vigilance reports, ((b)(4) & (b)(4)).This mdr is related to (b)(4) for the event related to the second patient in the description 'separate child requiring an emergency tracheotomy change following blocking off' (2nd potential serious incident in scope of this mdr, aerogen reference (b)(4)).The first potential serious incident will be reported under a further mdr, aerogen reference (b)(4).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, any remedial actions taken and patient outcome.Aerogen have requested device return, the availability of the device will determine the potential investigation route which will be outlined in the subsequent report.Aerogen 's clinical support specialist has also engaged with the healthcare professional to clarify aerogen positioning with this patient population as per instructions for use.Additionally based on the complaint feedback on the quick starter guide, aerogen are in the process of completing a full review of of the device labeling , including instruction manuals and quick starter guides, this investigation will be outlined in the subsequent report.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 intented 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.
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Event Description
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On (b)(6) 2021 aerogen were notified of 2 potential serious incidents from (b)(6) hospital in the uk, related to paediatric patients in the paediatric intensive care unit (picu) with use of the aerogen solo nebuliser and tracheotomy placement.This mdr is for the 2nd potential serious incident, (aerogen reference (b)(4)).The complaint outlined that the healthcare providers in the picu followed the aerogen set up guide in which nebulisers were not delivered properly, which resulted in emergency situations with children blocking off tracheotomy tubes and requiring emergency changes.The reporter stated the following on use of the aerogen set up guide 'the guide demonstrates photos and states the use of the nebuliser attached to the inlet chamber of the humidifier, however, nowhere does it state this is only for use on dual limb circuits or airvo's.Nowhere does it state for use on single limb circuits with exhalation valves.The aerosol leaks out of the exhalation port when the nebuliser is placed anywhere in the circuit below the exhalation port and therefore medication is not delivered to the detriment of the patient.After discussion with the rep, we have established in these ventilation circuits, such as breas and astral, the nebuliser must be situated above the exhalation valve.Also, in the quick reference guide nowhere does it state the solo 28 day change of the nebuliser and t piece is based on intermittent use of less than 4 times per day.As a consequence, staff have used it more frequently for 0.9% sodium chloride nebulisers and this had crystalised the mesh, stopping the solo working.This has again led to a nebuliser not getting delivered (1st potential serious incident not in scope of this mdr, aerogen reference (b)(4)) and a separate child requiring an emergency tracheotomy change following blocking off.' (2nd potential serious incident in scope of this mdr, aerogen reference (b)(4)).On follow up, the aerogen clinical support specialist received information that the patient required an emergency tracheostomy tube change.This would mean that the patient was struggling to breathe.Clarification on number of tube changes not provided.The initial reporter confirmed that information on patient age and date of the event was not available.There was no discomfort or pain for the patient apart from their tracheostomy getting blocked and needing changing.There were no serious negative patient outcome apart from the need to do an emergency trachy changes, which was the only reported medical intervention required.The patient was in the hospital's high dependency unit (hdu).Device not available for return, discarded by user.
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Manufacturer Narrative
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The complaint referred to 2 potential serious incidents and aerogen have separated into two complaint files and vigilance reports, ((b)(4)).This mdr is related to (b)(4) for the event related to the second patient in the description 'separate child requiring an emergency tracheotomy change following blocking off' (2nd potential serious incident in scope of this mdr, aerogen reference (b)(4) ).The first potential serious incident will be reported under a further mdr, aerogen reference (b)(4).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, any remedial actions taken and patient outcome.Aerogen have requested device return, the availability of the device will determine the potential investigation route which will be outlined in the subsequent report.Aerogen 's clinical support specialist has also engaged with the healthcare professional to clarify aerogen positioning with this patient population as per instructions for use.Additionally based on the complaint feedback on the quick starter guide, aerogen are in the process of completing a full review of the device labeling , including instruction manuals and quick starter guides, this investigation will be outlined in the subsequent report.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.Update 14th february 2022: follow up report is submitted for additional information received from the initial reporter on the (b)(6) 2022.
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Manufacturer Narrative
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The complaint referred to 2 potential serious incidents and aerogen have separated into two complaint files and vigilance reports, ((b)(4)).This mdr is related to (b)(4) for the event related to the second patient in the description 'separate child requiring an emergency tracheotomy change following blocking off' (2nd potential serious incident in scope of this mdr, aerogen reference (b)(4)).The first potential serious incident will be reported under a further mdr, aerogen reference (b)(4).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, any remedial actions taken and patient outcome.Aerogen have requested device return, the availability of the device will determine the potential investigation route which will be outlined in the subsequent report.Aerogen 's clinical support specialist has also engaged with the healthcare professional to clarify aerogen positioning with this patient population as per instructions for use.Additionally based on the complaint feedback on the quick starter guide, aerogen are in the process of completing a full review of the device labeling , including instruction manuals and quick starter guides, this investigation will be outlined in the subsequent report.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.Please note that aerogen solo use with tracheostomy is not an approved intented 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.Update 14th february 2022: follow up report is submitted for additional information received from the initial reporter on the (b)(6) and (b)(6) 2022.The report has been updated.Update 23rd march 2022: follow up report is submitted for additional information of investigation conclusions completed.The report has been updated for the following fields only and narrative below: b4, d3 - correction of country, e1- country, g1-country, post code, g3, g6, h6.Aerogen have taken the appropriate measures to review and investigate the complaint received, including the following: 1.Aerogen have requested device return for investigation, however the initial reporter confirmed the device was discarded and is not available for return.Therefore, no device investigation was possible for this event.2.Risk assessment has been completed to summarize the risk analysis conducted per aerogen's risk management procedures and en iso 14971.This assessment included review of applicable labelling (instruction manual, quick reference guide), risk management documents and clinical risk assessment.The risk assessment is provided as appendix 1 along with this report.3.Clinical assessment has been completed for review of the event and clinical determination of potential to attribute to serious incident.The assessment included review of potential medical interventions that may be required and potential medical implications to the patient.This clinical assessment is provided as appendix 2 along with this report.In conclusion, as outlined within the risk assessment, from the manufacturer's investigations conducted to date, as outlined above, per aerogen risk management procedure dp008, of the patient harm in question "no or incomplete or prolonged drug delivery" has the associated severity of "marginal".Therefore, "marginal" severity x "rare" ((b)(4)) occurrence = iv = low risk.As per dp008 definitions, low risks are considered acceptable and must be assessed to ensure no additional risk control measures are possible.The product does not present risks to patients or users in a manner which had not already been anticipated.No new harms are being introduced as a result of this complaint.Updates to solo shuma (systems hazards and user misuse analysis) are advised for clarification to describe how the hazard of placement of the nebuliser in relation to the leak port of the tracheostomy tube is the same as the niv (non-invasive ventilation) placement.The mitigations listed include: · the human factors protocol checks that the instruction manual is easy to follow and that the system is not difficult to assemble.· usability testing of solo and the pro-x control module for homecare environment system · the instruction manual instructs on correct system assembly · the instruction manual instructs and provides illustrations for connecting the nebuliser to a paediatric breathing circuit.In summary, the hazards detailed in the customer complaint do not impact the documented severity, occurrence, pre or post mitigation values of the existing hazards and it has been assessed that minor clarifications are required to be added to align with the instruction manual updates.The safety and clinical performance of the parts in the scope of this risk assessment are not affected.There is no change to the intended use of the devices.There is no change to the indications for use.There is no change to patient contacting materials.There will be no new protective measures introduced.There are no new risks or additional harms being introduced as a result of this assessment.Additionally, from clinical review, reference appendix 2, it is clear that normal saline (ns) nebulisation is an accepted clinical adjunct therapy in tracheostomized and invasive mechanical ventilation (imv) 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 (suctioning/mucolytics etc.) are central in the prevention of tt occlusion.Therefore, with regard to these specific instances in which 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 prior to an intentional leak port, as occurred in these incidents, 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.This incident has been categorized by aerogen as a reportable incident, with no known problem identified with the device in scope with device not available for return.As per complaint description provided there is no indicated performance failure nor indication that the device did not function as intended.Investigations completed conclude the event is traced to the user not following the manufacturing instructions.Sales of solo devices from calendar year 2021 totaled (b)(4).If assumed a percentage of those sales were used in the icu and a percentage of those devices were required for tracheostomy intervention, then we take the worst-case scenario that (b)(4) of total sales were customer complaint # (b)(4) for tracheostomy patients.Complaints of this nature have not been reported in that time therefore these 2 complaints result in the probability of (b)(4), which equates to "rare" on aerogen's risk probability scale.Therefore, based on assessments completed to date there are no further actions determined by aerogen at this time, and aerogen will continue to monitor complaints received, the occurrence rating and severity of the risk as per aerogen's quality management system.
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Event Description
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On (b)(6) 2021 aerogen were notified of 2 potential serious incidents from (b)(6) hospital in the uk, related to paediatric patients in the paediatric intensive care unit (picu) with use of the aerogen solo nebuliser and tracheotomy placement.This mdr is for the 2nd potential serious incident, (aerogen reference (b)(4)).The complaint outlined that the healthcare providers in the picu followed the aerogen set up guide in which nebulisers were not delivered properly, which resulted in emergency situations with children blocking off tracheotomy tubes and requiring emergency changes.The reporter stated the following on use of the aerogen set up guide.'the guide demonstrates photos and states the use of the nebuliser attached to the inlet chamber of the humidifier, however, nowhere does it state this is only for use on dual limb circuits or airvo's.Nowhere does it state for use on single limb circuits with exhalation valves.The aerosol leaks out of the exhalation port when the nebuliser is placed anywhere in the circuit below the exhalation port and therefore medication is not delivered to the detriment of the patient.After discussion with the rep, we have established in these ventilation circuits, such as breas and astral, the nebuliser must be situated above the exhalation valve.Also, in the quick reference guide nowhere does it state the solo 28 day change of the nebuliser and t piece is based on intermittent use of less than 4 times per day.As a consequence, staff have used it more frequently for 0.9% sodium chloride nebulisers and this had crystalised the mesh, stopping the solo working.This has again led to a nebuliser not getting delivered (1st potential serious incident not in scope of this mdr, aerogen reference (b)(4)) and a separate child requiring an emergency tracheotomy change following blocking off.' (2nd potential serious incident in scope of this mdr, aerogen reference (b)(4)).On follow up, the aerogen clinical support specialist received information that the patient required an emergency tracheostomy tube change.This would mean that the patient was struggling to breathe.Clarification on number of tube changes not provided.The initial reporter confirmed that information on patient age and date of the event was not available.There was no discomfort or pain for the patient apart from their tracheostomy getting blocked and needing changing.There were no serious negative patient outcome apart from the need to do an emergency trachy changes, which was the only reported medical intervention required.The patient was in the hospital's high dependency unit (hdu).Device not available for return, discarded by user.
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Search Alerts/Recalls
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