MAUDE Adverse Event Report: AEROGEN LIMITED AEROGEN SOLO NEBULIZER

Model Number AS-AG3001

Device Problem Use of Device Problem (1670)

Patient Problem High Pulmonary Arterial Wedge Pressure (2480)

Event Date 07/24/2023

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 and had requested the return of the device.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

On the 20th of september 2023, aerogen received the following complaints via medwatch (report number:(b)(4)) as per the report ' the device failed to nebulize epoprostenol medication shortly after it was initiated.Multiple attempts to flush the nebulizer and restart medication were unsuccessful.The device would briefly resume nebulizing the medication, but only for short periods of time.This led to an increase in the patient's pulmonary artery (pa) pressures.Of note-this pump does not have an alarm when a patient is not being nebulized to alert staff.If the pump would have an alarm, staff would be notified when it is not nebulizing.What was the original intended procedure? : patient was receiving nebulized epoprostenol (veletri) in-line with their mechanical ventilator via the aerogen solo neb.What problem did the user have (check all that apply) :device was hard to use;" 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 and had requested the return of the device.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: 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.The delivery of veletri (epoprostenol) using the aerogen solo system by inhalation is considered abnormal use for aerogen devices.The delivery of veletri by inhalation is considered an unapproved use as per this medications spc (summary of product characteristics).Risk assessment: analysis of aerogens risk documentation, has identified the risk of "no or incomplete or prolonged drug delivery" as the resultant patient harm from treatment using off-label or unlicensed drug.This is deemed to have a low overall risk level.The aerogen solo system instruction for use (ifu) states that the aerogen solo is intended for hospital use only to nebulise physician-prescribed medications for inhalation which are approved for use with a general-purpose nebuliser.In the reported incident, multiple attempts to flush the nebuliser and restart medication were unsuccessful.The health care professional reported that this led to an increase in the patient's systolic pulmonary artery pressures from 40s to 70s mmhg, with a consequent increased use of vasopressors required.It is possible that failure to continuously nebulise epoprostenol (veletri) contributed to the patient impact observed as an increase in pulmonary artery pressure.The delivery of veletri (epoprostenol) using the aerogen solo system by inhalation is considered abnormal use for aerogen devices.The delivery of veletri by inhalation is considered an unapproved use as per this medications summary of product characteristics.The aerogen solo nebuliser system is a non-invasive, short-term non-active class iia medical device that is intended to channel aerosolized prescription medication for introduction into the body, per rule 11 annex ix mdd (medical device directive) 93/42/eec.It is important to note upfront that the aerogen solo system is not intended for life sustaining or life supporting delivery of medication.This incident can be attributed to abnormal use.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: the clinical status of the patient wasn't specified for the current incident.The aerogen device reportedly failed to nebulise epoprostenol medication shortly after it was initiated.It was reported that multiple attempts to flush the nebuliser and restart medication were unsuccessful.The hcp reported that this led to an increase in the patient's systolic pulmonary artery pressures from 40s to 70s mmhg, with a consequent increased use of vasopressors required.Veletri (epoprostenol) is approved for delivery as an intravenous injectable solution only, with a treatment indication for pulmonary arterial hypertension in patients with who functional class i symptoms to improve exercise capacity.Veletri is only indicated for continuous infusion by intravenous route.Continuous delivery of veletri by inhalation via aerogen devices is not an approved indication nor is it an approved use of aerogen devices as aerosolisation/inhalation is not an approved method of administration per this medications summary of product characteristics (spc).Determination the delivery of veletri (epoprostenol) using the aerogen solo system by inhalation is considered abnormal use for aerogen devices.The delivery of veletri by inhalation is considered an unapproved use as per this medications summary of product characteristics.The delivery of veletri (epoprostenol) using the aerogen solo system by inhalation is considered abnormal use for aerogen devices.Nevertheless, it is possible that failure to continuously nebulise epoprostenol (veletri) contributed to the patient impact observed.

Event Description

On the 20th of september 2023, aerogen received the following complaints via medwatch (report number:2600320000-2023-8148) as per the report ' the device failed to nebulize epoprostenol medication shortly after it was initiated.Multiple attempts to flush the nebulizer and restart medication were unsuccessful.The device would briefly resume nebulizing the medication, but only for short periods of time.This led to an increase in the patient's pulmonary artery (pa) pressures.Of note-this pump does not have an alarm when a patient is not being nebulized to alert staff.If the pump would have an alarm, staff would be notified when it is not nebulizing.What was the original intended procedure? : patient was receiving nebulized epoprostenol (veletri) in-line with their mechanical ventilator via the aerogen solo neb.What problem did the user have (check all that apply) :device was hard to use;" aerogens customer complaints team are currently investigating.

• Brand Name: AEROGEN SOLO NEBULIZER
• Type of Device: AEROGEN SOLO NEBULIZER
• 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, ; EI ; 3539154040
• MDR Report Key: 17893020
• MDR Text Key: 325284191
• Report Number: 3003399703-2023-21931
• 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
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AS-AG3001
• 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: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other