MAUDE Adverse Event Report: AEROGEN LTD AEROGEN SOLO NEBULISER SYSTEM

Model Number AG-AS3200-US

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pulmonary Edema (2020)

Event Date 11/30/2022

Event Type  Injury  

Event Description

Paediatric respiratory therapist was giving 12ml/hr continuous dosing to an 8 month old paediatric patient and was causing pulmonary edema.The aerogen solo was placed on the dry side of the heater on a neonatal circuit when it should have been placed closer to the patient on the inspiratory limb as the dry side of the heater and diameter of the circuit causes significant rainout sending more moisture to the lungs.The order was for 5 mg of albuterol an hour via cnts, however they ran the pump at 12ml/ hour in error.The rate plus the increased rainout fluid overloaded the lungs.The patient subsequently made a full recovery.Aerogens complaint team are in continued follow up with the initial reported for additional information on the event.The device has already been discarded and is not available for return to aerogen.

Manufacturer Narrative

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, however, the initial reporter indicated device was disposed of.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.

Event Description

Paediatric respiratory therapist was giving 12ml/hr continuous dosing to an 8 month old paediatric patient and was causing pulmonary edema.The aerogen solo was placed on the dry side of the heater on a neonatal circuit when it should have been placed closer to the patient on the inspiratory limb as the dry side of the heater and diameter of the circuit causes significant rainout sending more moisture to the lungs.The order was for 5 mg of albuterol an hour via cnts, however they ran the pump at 12ml/ hour in error.The rate plus the increased rainout fluid overloaded the lungs.The patient subsequently made a full recovery.Aerogens complaint team are in continued follow up with the initial reported for additional information on the event.The device has already been discarded and is not available for return to aerogen.

Manufacturer Narrative

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, however, the initial reporter indicated device was disposed of.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.No additional information was received and the device was not available for return, therefore aerogen have completed the investigation with information available and no device returned.Clinical assessment: rain-out is usually condensation of humidified gas and to a lesser extent aerosolised drug that deposits as droplets within the breathing circuit.Clinicians often prefer to place the nebuliser at the dry side of the humidifier for a variety of reasons including less rain-out at the wye, as per the current incident.From the available evidence, it is possible that continuous albuterol delivery through a heated humidified circuit could lead to increased rain-out in the ventilator circuit.This may have contributed to the patient impact observed that manifested clinically as pulmonary edema.Pulmonary 3 edema can develop from increased pressure in the microcirculation of the lungs as seen with sustained hypoxia.It can't be discounted that clinical deterioration may have occurred anyway.In the absence of additional information, no further assumption can be drawn on the impact of the aerogen device in the current incident and no root cause can be determined.Based on investigations completed no further actions are determined by aerogen at this time, and aerogen will continue to monitor complaints received, the occurrence rating and severity of the risk as per aerogens quality management system.Risk assessment: risk assessment has been completed to summarize the risk analysis conducted per aerogen's risk management procedures and en iso 14971.Analysis of the aerogen ltd risk management documentation solo shuma sha99-118 identifies the risk of "incorrect (high flow) setting for syringe type selected on the pump" as a result of no or incomplete drug delivery to the patient based on the event description for this complaint.This type of risk would likely result in inconvenience or temporary discomfort to patient/caregiver.The primary conclusion of this risk assessment indicates that continuous albuterol delivery through a heated humidified circuit could lead to increased rain-out in the ventilator circuit.This may have contributed to the patient impact observed that manifested clinically as pulmonary edema.The reported positioning of the aerogen device at the dry side of the humidifier is considered on-label for aerogen devices.In addition, there are no customer complaints directly related to this issue.Market feedback will continue to be monitored through the aerogen customer complaints process.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.The device was not returned for investigation.Therefore, based on assessments completed to date and in the absence of the device for testing, no further assumption can be drawn on device function.The hcp confirmed the order was for 5 mg of albuterol an hour via cnts and they ran the pump at the maximum 12ml/ hour as stated in the aerogen solo instructions for use (30- 674 rev l), rather than determining the required flow for the correct dose of the medication required for the patient.Based on investigations completed no further actions are determined to be required 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.

Manufacturer Narrative

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, however, the initial reporter indicated device was disposed of.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.Follow up report 1: update fields.No additional information was received and the device was not available for return, therefore aerogen have completed the investigation with information available and no device returned.Clinical assessment: rain-out is usually condensation of humidified gas and to a lesser extent aerosolised drug that deposits as droplets within the breathing circuit.Clinicians often prefer to place the nebuliser at the dry side of the humidifier for a variety of reasons including less rain-out at the wye, as per the current incident.From the available evidence, it is possible that continuous albuterol delivery through a heated humidified circuit could lead to increased rain-out in the ventilator circuit.This may have contributed to the patient impact observed that manifested clinically as pulmonary edema.Pulmonary 3 edema can develop from increased pressure in the microcirculation of the lungs as seen with sustained hypoxia.It can't be discounted that clinical deterioration may have occurred anyway.In the absence of additional information, no further assumption can be drawn on the impact of the aerogen device in the current incident and no root cause can be determined.Based on investigations completed no further actions are determined by aerogen at this time, and aerogen will continue to monitor complaints received, the occurrence rating and severity of the risk as per aerogens quality management system.Risk assessment: risk assessment has been completed to summarize the risk analysis conducted per aerogen's risk management procedures and en iso 14971.Analysis of the aerogen ltd risk management documentation solo shuma sha99-118 identifies the risk of "incorrect (high flow) setting for syringe type selected on the pump" as a result of no or incomplete drug delivery to the patient based on the event description for this complaint.This type of risk would likely result in inconvenience or temporary discomfort to patient/caregiver.The primary conclusion of this risk assessment indicates that continuous albuterol delivery through a heated humidified circuit could lead to increased rain-out in the ventilator circuit.This may have contributed to the patient impact observed that manifested clinically as pulmonary edema.The reported positioning of the aerogen device at the dry side of the humidifier is considered on-label for aerogen devices.In addition, there are no customer complaints directly related to this issue.Market feedback will continue to be monitored through the aerogen customer complaints process.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.The device was not returned for investigation.Therefore, based on assessments completed to date and in the absence of the device for testing, no further assumption can be drawn on device function.The hcp confirmed the order was for 5 mg of albuterol an hour via cnts and they ran the pump at the maximum 12ml/ hour as stated in the aerogen solo instructions for use (30- 674 rev l), rather than determining the required flow for the correct dose of the medication required for the patient.Based on investigations completed no further actions are determined to be required 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.Update on the 12th of january: follow up report 2 submitted for the addition of investigation codes.The report has been updated for the following fields, b4,g6,h2 and h6.

Event Description

Paediatric respiratory therapist was giving 12ml/hr continuous dosing to an 8 month old paediatric patient and was causing pulmonary edema.The aerogen solo was placed on the dry side of the heater on a neonatal circuit when it should have been placed closer to the patient on the inspiratory limb as the dry side of the heater and diameter of the circuit causes significant rainout sending more moisture to the lungs.The order was for 5 mg of albuterol an hour via cnts, however they ran the pump at 12ml/ hour in error.The rate plus the increased rainout fluid overloaded the lungs.The patient subsequently made a full recovery.Aerogens complaint team are in continued follow up with the initial reported for additional information on the event.The device has already been discarded and is not available for return to aerogen.

• Brand Name: AEROGEN SOLO NEBULISER 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: thelma marley ; galway business park; dangan; galway, H91EH-6C ; EI H91EH6C
• MDR Report Key: 16128913
• MDR Text Key: 306985479
• Report Number: 3003399703-2022-21459
• 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: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AG-AS3200-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 12/14/2022; 12/14/2022
• Supplement Dates FDA Received: 03/24/2023; 01/12/2024
• 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: 8 MO