MAUDE Adverse Event Report: AEROGEN LTD AEROGEN SOLO NEBULIZER SYSTEM

Model Number AG-AS3001

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/02/2021

Event Type  Injury  

Manufacturer Narrative

As per the event description provided, aerogen have reviewed the event and determined that the event caused the worsening of respiratory distress to the patient and has the potential to attribute to a serious injury of the patient if the event was to reoccur.In a conservative assessment completed based on the initial information received to date with no device return a potential device malfunction was chosen as per aerogen's vigilance procedure definition 'the failure of a device to meet its performance specifications or otherwise perform as intended.Performance specifications include all claims made in the labelling for the device.The intended performance of a device refers to the intended use for which the device is labelled or marketed.' as per the event description performance of the nebulizer was not met for nebulizing the drug approved for inhalation pathway.Aerogen have taken the appropriate measures to review and investigate the complaint received.The aerogen us clinical care specialist has also provided communication to the customer to offer clinical assistance/troubleshooting guidance.On receipt of additional information on the event aerogen are reviewing and determining the investigation pathway.This will be communicated in a follow up report.The device is not available for return and has been discarded by the reporting hospital.

Event Description

On (b)(6) 2022 an aerogen employee (critical care specialist) in the us received communication from a clinical specialist from (b)(6) hospital in (b)(6) related to an event involving an aerogen device.On becoming aware of the event, the aerogen customer complaints representative along with the aerogen us clinical care specialist, requested additional information from the reporter.The aerogen us clinical care specialist has also provided communication to the customer to offer clinical assistance/troubleshooting guidance.The event occurred on the (b)(6) 2021.The reporter referenced the event was related to an 'issue with pressure bubbling back into the solo cup from the pressure of the vent.' the following description was provided by the aerogen critical care specialist upon communication from the reporter in (b)(6) hospital: 'the aerogen solo device was in use with the vdr-4 percussionaire ventilator (exact setting unknown) where the patient is intubated and is invasive ventilation.The event involved a pediatric patient.A video was provided by the reporter which showed significant back pressure with bubbling, and it can be observed that the medication is being pushed out of the small air port that allows the solo to evacuate entrained air within the medication cup.Medication in use was albuterol, continuous drug delivery.Estimated that the event occurred within 12 hours of the device being used.Troubleshooting completed by the team at time of the event was to the check of all connections, reprimed tube set line, changed solo cup, and the issue was resolved with use of a new aerogen solo device'.During this event the paediatric patient was starting to revert back into more significant respiratory distress, but when placing the replacement device (aerogen solo) that operated as expected patient improvement resumed as expected.The device was discarded and is not available for return.On (b)(6) 2022 aerogen's global medical affairs manager discussed the event in further detail with the initial reporter.The time to discovery of the event was immediate and she confirmed there was no permanent harm to the patient.She confirmed any issues noted were temporary and resolved quickly.Albuterol was the only medication being delivered by inhalation to this patient.Clinical deterioration leading to change of device: decreased stats into low 90's and elevated tcom from 47 to 60.Remediation action by hospital: solo and controller (prox) swapped out.Replacement aerogen devices worked with no issues.

Manufacturer Narrative

As per the event description provided, aerogen have reviewed the event and determined that the event caused the worsening of respiratory distress to the patient and has the potential to attribute to a serious injury of the patient if the event was to reoccur.In a conservative assessment completed based on the initial information received to date with no device return a potential device malfunction was chosen as per aerogen's vigilance procedure definition 'the failure of a device to meet its performance specifications or otherwise perform as intended.Performance specifications include all claims made in the labelling for the device.The intended performance of a device refers to the intended use for which the device is labelled or marketed.' as per the event description performance of the nebulizer was not met for nebulizing the drug approved for inhalation pathway.Aerogen have taken the appropriate measures to review and investigate the complaint received.The aerogen us clinical care specialist has also provided communication to the customer to offer clinical assistance/troubleshooting guidance.On receipt of additional information on the event aerogen are reviewing and determining the investigation pathway.This will be communicated in a follow up report.The device is not available for return and has been discarded by the reporting hospital.Follow up report 1, additional informatoin for confirmatin of date of event, updated the following fields only: b3 - date of event.B4 - date of this report.B5 - change of date of event only.G3 - date received.G6 - follow up report.H2- additional information.

Event Description

On (b)(6) 2022 an aerogen employee (critical care specialist) in the us received communication from a clinical specialist from (b)(6) hospital in (b)(6) in usa related to an event involving an aerogen device.On becoming aware of the event, the aerogen customer complaints representative along with the aerogen us clinical care specialist, requested additional information from the reporter.The aerogen us clinical care specialist has also provided communication to the customer to offer clinical assistance/troubleshooting guidance.The event occurred on the (b)(6) 2021.The reporter referenced the event was related to an 'issue with pressure bubbling back into the solo cup from the pressure of the vent.' the following description was provided by the aerogen critical care specialist upon communication from the reporter in (b)(6) hospital: 'the aerogen solo device was in use with the vdr-4 percussionaire ventilator (exact setting unknown) where the patient is intubated and is invasive ventilation.The event involved a pediatric patient.A video was provided by the reporter which showed significant back pressure with bubbling, and it can be observed that the medication is being pushed out of the small air port that allows the solo to evacuate entrained air within the medication cup.Medication in use was albuterol, continuous drug delivery.Estimated that the event occurred within 12 hours of the device being used.Troubleshooting completed by the team at time of the event was to the check of all connections, reprimed tube set line, changed solo cup, and the issue was resolved with use of a new aerogen solo device'.During this event the paediatric patient was starting to revert back into more significant respiratory distress, but when placing the replacement device (aerogen solo) that operated as expected patient improvement resumed as expected.The device was discarded and is not available for return.On the (b)(6) 2022 aerogen's global medical affairs manager discussed the event in further detail with the initial reporter.The time to discovery of the event was immediate and she confirmed there was no permanent harm to the patient.She confirmed any issues noted were temporary and resolved quickly.Albuterol was the only medication being delivered by inhalation to this patient.Clinical deterioration leading to change of device: decreased stats into low 90's and elevated tcom from 47 to 60.Remediation action by hospital: solo and controller (prox) swapped out.Replacement aerogen devices worked with no issues.

Manufacturer Narrative

As per the event description provided, aerogen have reviewed the event and determined that the event caused the worsening of respiratory distress to the patient and has the potential to attribute to a serious injury of the patient if the event was to reoccur.In a conservative assessment completed based on the initial information received to date with no device return a potential device malfunction was chosen as per aerogen's vigilance procedure definition 'the failure of a device to meet its performance specifications or otherwise perform as intended.Performance specifications include all claims made in the labelling for the device.The intended performance of a device refers to the intended use for which the device is labelled or marketed.' as per the event description performance of the nebulizer was not met for nebulizing the drug approved for inhalation pathway.Aerogen have taken the appropriate measures to review and investigate the complaint received.The aerogen us clinical care specialist has also provided communication to the customer to offer clinical assistance/troubleshooting guidance.On receipt of additional information on the event aerogen are reviewing and determining the investigation pathway.This will be communicated in a follow up report.The device is not available for return and has been discarded by the reporting hospital.The following investigations have been completed and are documented within follow up report 2: risk assessment: risk assessment has been completed to summarize the risk analysis conducted per aerogen's risk management procedures and en iso 14971.As per risk analysis conclusion, the investigation found that the nebuliser which stopped due to bubbling was a solo ii assembly design (90-120).Fizzing/bubbling is a known feature with the aerogen vibrating mesh technology and as a result, aerogen has addressed such issues with an updated solo nebuliser 90-196 (solo ii assembly (new top seal)) which is in stages of commercialization.Solo nebuliser 90-196 is designed with the objective of eliminating the potential for bubbles to stagnate in the nebuliser throat, which has been identified as the root cause to nebuliser interruption/stoppage.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.Continued monitoring of customer complaints will be completed to analyse the performance of the solo nebuliser 90-196 (solo ii assembly (new top seal)) in relation to bubble interruption.No further action is required at this stage.Clinical assessment: clinical assessment has been completed for review of the event and clinical determination of potential to attribute to serious incident.The available evidence indicates that the patient impact reported could occur due to the reported failure of the aerogen device system and the resulting impaired delivery of continuous medication to a critically ill patient.However, the timeline of events is not clear from the available information, it is unclear how long the patient was on continuous albuterol prior to the clinical deterioration.Given that the patient was critically ill a clinical deterioration of this nature could also have occurred even if the aerogen device was functioning normally.The device was not returned for additional device investigation.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.The follow up 2 reports is being submitted as the final report, the event investigations have been concluded and the complaint will be closed as per aerogen's quality management system.Should the aforementioned preposition change by the time the complaint is officially closed, the new and/or additional information will be provided to fda through a further mdr report as applicable.

Event Description

On 19th january 2022 an aerogen employee (critical care specialist) in the us received communication from a clinical specialist from (b)(6) hospital in (b)(6) in usa related to an event involving an aerogen device.On becoming aware of the event, the aerogen customer complaints representative along with the aerogen us clinical care specialist, requested additional information from the reporter.The aerogen us clinical care specialist has also provided communication to the customer to offer clinical assistance/troubleshooting guidance.The event occurred on the 2nd december 2021.The reporter referenced the event was related to an 'issue with pressure bubbling back into the solo cup from the pressure of the vent.' the following description was provided by the aerogen critical care specialist upon communication from the reporter in (b)(6) hospital: 'the aerogen solo device was in use with the vdr-4 percussionaire ventilator (exact setting unknown) where the patient is intubated and is invasive ventilation.The event involved a pediatric patient.A video was provided by the reporter which showed significant back pressure with bubbling, and it can be observed that the medication is being pushed out of the small air port that allows the solo to evacuate entrained air within the medication cup.Medication in use was albuterol, continuous drug delivery.Estimated that the event occurred within 12 hours of the device being used.Troubleshooting completed by the team at time of the event was to the check of all connections, reprimed tube set line, changed solo cup, and the issue was resolved with use of a new aerogen solo device'.During this event the paediatric patient was starting to revert back into more significant respiratory distress, but when placing the replacement device (aerogen solo) that operated as expected patient improvement resumed as expected.The device was discarded and is not available for return.On the 4th february 2022 aerogen's global medical affairs manager discussed the event in further detail with the initial reporter.The time to discovery of the event was immediate and she confirmed there was no permanent harm to the patient.She confirmed any issues noted were temporary and resolved quickly.Albuterol was the only medication being delivered by inhalation to this patient.Clinical deterioration leading to change of device: decreased stats into low 90's and elevated tcom from 47 to 60.Remediation action by hospital: solo and controller (prox) swapped out.Replacement aerogen devices worked with no issues.

• Brand Name: AEROGEN SOLO NEBULIZER SYSTEM
• Type of Device: NEBULIZER
• Manufacturer (Section D): AEROGEN LTD; galway business park; dangan; galway, H91 E H6C; EI H91 EH6C
• Manufacturer (Section G): AEROGEN LTD.; galway business park; dangan; galway, H91EH 6C; EI H91EH6C
• Manufacturer Contact: thelma marley ; galway business park; dangan; galway, H91 E-H6C ; EI H91 EH6C
• MDR Report Key: 13535517
• MDR Text Key: 288998906
• Report Number: 3003399703-2022-20919
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AG-AS3001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 MO
• Patient Sex: Female
• Patient Weight: 6 KG