MAUDE Adverse Event Report: AEROGEN LIMITED AEROGEN SOLO NEBULISER

Model Number AG-AS3001

Device Problem Insufficient Information (3190)

Patient Problems Low Oxygen Saturation (2477); Increased Respiratory Rate (2486); Wheezing (4463)

Event Date 10/26/2023

Event Type  Injury  

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.A review per aerogen's 'field correction/removal procedure' was completed based on this complaint received.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

On the 02nd of november, aerogen were notified of the following event: 'i had an 8 month old pediatric patient on airvo on the night of thursday, oct 26.He was admitted with reactive airways the day prior and was receiving q2h ventolin.I was called to see him at the beginning of my shift for increased wob, low spo2 and audible wheezing.When i got down to assess him, i checked over his airvo and noticed his aerogen cup was filled to the top.I asked his nurse if she noticed this and she said she had been putting in his nebs with the cup still full.I explained to her that the cup empties completely between doses.I tried nebulizing what was in the aerogen, but quickly noted that it was not nebulizing.I switched out the cup and tried running a new neb which worked for about 3/4 of the dose and then it stopped nebulizing again.I took the cup out, tilted it so the medication was off of the mesh for a few seconds, and then tried again and it started working.I aspirated and measured how much ventolin was sitting in the old cup and it was nearly 6mls, which meant the patient hadn't received any medication for about 6 hours'.It was confirmed the device has been discarded and is not available for investigation.No serial number is available.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 further information from the reporting healthcare worker to determine further details on the event.A review per aerogen's 'field correction/removal procedure' was completed based on this complaint received.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: the report has been updated for the aforementioned fields and the narrative below only: aerogen have taken the appropriate measures to review and investigate the complaint received.The device was not available for return and investigation and therefore no conclusion could be drawn on the device function.Risk and clinical assessment were completed as part of the investigation.Risk assessment: aerogen ltd risk management documentation, aerogen solo shuma (b)(4) identifies harms to the patient as a result of delayed or inhibited nebulization.Aerogen solo system is considered non-invasive, class iia per annex ix, rule 11 of mdd 93/42/eec is intended to aerosolise physician-prescribed solutions for inhalation to paediatric (29 days and older) and adult patients on and off ventilation or other positive pressure breathing assistance in the hospital environment.Aerogen solo system is not intended for life sustaining or life supporting delivery of medication.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 introduced because of this assessment.Clinical assessment: the patient involved was admitted for reactive airway disease and was reportedly "improving" with aerosolised bronchodilator therapy upon admission.Reactive airways disease is an asthma-like illness that develops after a single high-level exposure to a pulmonary irritant.Symptoms may include cough, wheezing, and dyspnoea.The patient's deterioration the next day, noted by a respiratory therapist who was alerted by other medical staff included increased work of breathing, low spo2 of 87% (in most a healthy spo2 being 95-100%) and audible wheezing i.E., symptoms consistent with the presenting problem.The complainant reported that the aerogen solo nebuliser was "not functioning properly" and was full.Upon replacing the nebuliser, and the patient receiving their treatment (ventolin) their clinical condition reportedly "improved".The information available suggests the clinical status of the patient was improving prior to the incident.It is medically plausible that the potential device failure, resulting in a failure to aerosolise the prescribed medication, could contribute to the reported deterioration and patient symptoms described.Ventolin (albuterol) summary bronchodilators including ventolin provide relief of symptoms such as wheezing, shortness of breath, cough, and tightness in the chest by relaxing bronchial smooth muscle through action on b2-receptors.Ventolin (albuterol) has an extensive literature supporting its safety and efficacy in paediatric patients.In canada (the location of the hospital involved), ventolin nebules are indicated for use in the treatment of severe bronchospasm associated with exacerbations of chronic bronchitis and bronchial asthma in adults and children (5 years and older).Ventolin nebules are to be used with a nebuliser under the direction of a physician.Ventolin nebuliser solution, per the available spcs, is approved for inhalation and for use with a general-purpose nebuliser, as no specific nebuliser is named.Therefore, the use of this drug in canada with the aerogen solo is considered on-label for aerogen devices.Based on the available information a relationship between the patient's reported deterioration and the potential failure of the manufactured device (aerogen solo) is reasonably possible.As the device was not returned for investigation a conclusion on the alleged malfunction cannot be determined.

Event Description

On the 2nd of november, aerogen were notified of the following event: 'i had an 8 month old pediatric patient on airvo on the night of thursday, oct 26.He was admitted with reactive airways the day prior and was receiving q2h ventolin.I was called to see him at the beginning of my shift for increased wob, low spo2 and audible wheezing.When i got down to assess him, i checked over his airvo and noticed his aerogen cup was filled to the top.I asked his nurse if she noticed this and she said she had been putting in his nebs with the cup still full.I explained to her that the cup empties completely between doses.I tried nebulizing what was in the aerogen, but quickly noted that it was not nebulizing.I switched out the cup and tried running a new neb which worked for about 3/4 of the dose and then it stopped nebulizing again.I took the cup out, tilted it so the medication was off of the mesh for a few seconds, and then tried again and it started working.I aspirated and measured how much ventolin was sitting in the old cup and it was nearly 6mls, which meant the patient hadn't received any medication for about 6 hours'.It was confimed the device has been discarded and is not available for investigation.No serial number is available.Aerogens customer complaints team are currently investigating.

• Brand Name: AEROGEN SOLO NEBULISER
• Type of Device: AEROGEN SOLO NEBULISER
• Manufacturer (Section D): AEROGEN LIMITED; galway business park; dangan; galway, H91EH 6C; EI H91EH6C
• Manufacturer (Section G): AEROGEN LIMITED; 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: 18198708
• MDR Text Key: 328893314
• Report Number: 3003399703-2023-22032
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AG-AS3001
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8 MO
• Patient Sex: Male