MAUDE Adverse Event Report: AEROGEN LTD. AEROGEN SOLO NEBULIZER SYSTEM

Model Number AG-AS3001

Device Problems Connection Problem (2900); Insufficient Information (3190)

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

Event Date 02/11/2022

Event Type  Injury  

Event Description

On the (b)(6) 2022, an aerogen employee (clinical support specialist) was notified of an event related to an aerogen device which occurred on the (b)(6) 2022, at (b)(6).On becoming aware of the event, the aerogen clinical support specialist notified aerogen customer complaints team.The complaints representative requested additional information from the reporter.The initial reporter provided the following information: "(b)(6) admitted post cardiorespiratory arrest secondary to severe asthmatic attack.Transferred to the ward from picu on (b)(6) 2022 early morning, 05.00.Receiving hhfnc oxygen via airvo 2 - 15l/min and 28% o[?] receiving 4 hrly salbutamol 5mgs and ipratropium bromide 250 mcgs 6 hrly on ward.Had been receiving pulmozyme nebs in picu through ventilator but these were discontinued on (b)(6) 2022.Ward nurse administered nebs as prescribed and started nebs, green light visible as reported.Night of (b)(6) 2022 @ 23.00hrs, patient's wob increasing, rr and effort increased, very wheezy on auscultation of chest, o2 desaturations to 85-89%.Reviewed by medical and anaesthetic team, noted that increased fluid in aerogen chamber and alarm button orange.Aerogen set and tubing changed, noted to have 'drug residue' in chamber.Set disposed.Commenced hourly salbutamol nebs via new aerogen solo and administered freely, hhfnc flow increased to 40l/min and fio2 increased to 85%.Patient transferred to picu".In summary, the event is related to use of the aerogen solo nebuliser, on worsening of patient symptoms it was observed by the medical team that there was 'increased fluid' in the aerogen nebuliser chamber and the controller alarm button was orange.The amber alarm on the controller is an error indicator, it is unknown at this time whether a pro x controller or usb controller was utilized in this event with the aerogen solo nebuliser.The mode of use of the controller is not yet known.The initial reporter communicated that aerogen set and tubing were changed and was noted to have 'drug residue' in chamber.The device location is unknown and was indicated as 'disposed' in initial communications.Patient outcome after the event is unknown at this time.Aerogen complaints team are in continued follow up with the complainant for additional information on the event including confirmation of no device availability as per initial communication.

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, controller and mode of use and patient outcome.Aerogen have requested device return, the initial reporter indicated device was disposed, the availability of the device will determine the potential investigation route which will be outlined in the subsequent report.As per the event description the controller alarm signalled an error and there is no known device malfunction communicated to date.

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, controller and mode of use and patient outcome.Aerogen have requested device return, the initial reporter indicated device was disposed, the availability of the device will determine the potential investigation route which will be outlined in the subsequent report.As per the event description the controller alarm signalled an error and there is no known device malfunction communicated to date.Follow up report 1: updated fields: b5- updated as per 9th may communication.Aerogen have made 3 attempts with the initial reporter to retrieve additional information on the complaint.The initial reporter has confirmed no additional information will be provided on the 9th may 2022.Therefore, aerogen have completed investigation with the limited information available and no device return.Risk assessment: risk assessment has been completed to summarize the risk analysis conducted per aerogen's risk management procedures and en iso 14971.With the limited information received, and the confirmation from the initial reporter no further information would be provided, root cause cannot be determined but may be attributed to a disconnection between the controller cable and the nebuliser.If a controller nebuliser disconnection did occur, as demonstrated through the presence of an amber light, this may contribute to the increase of fluid within the nebuliser reservoir which aligns with the limited information received on the event.In the absence of additional information, no further assumption can be drawn on device function.A review of the existing shuma risk documentation for the solo nebuliser (sha99-118 rev be) and usb controller (sha99-213, rev p) was completed for potential failure/hazards for "no or incomplete drug delivery" based on the event description for this complaint.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 change to the intended use or indications for use as there is adequate instructions, warnings and troubleshooting around amber light display on the controllers and if there is remaining medication found in the nebuliser reservoir.Based on this, there will be no new protective measures introduced or no new risks or additional harms being introduced as a result of this assessment.In addition, a review was completed per aerogen's 'field correction/removal procedure' (qp049, rev l), based on this complaint received which may pose a risk to patients.Based on the risk assessment completed above, on the limited information received on this event, 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.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 likely occur due to a disconnection between the aerogen solo nebuliser and the controller (either aerogen usb controller or aerogen pro-x controller, not confirmed) as indicated within the applicable system manuals.This disconnection may have occurred due to user error.If a controller nebuliser disconnection did occur, as demonstrated through presence of amber light, this may contribute to the increase of fluid within the nebuliser reservoir which aligns with the limited information received on the event.In the absence of additional information, no further assumption can be drawn on device function.The reported use of salbutamol and ipratropium bromide with the aerogen solo and the reported positioning of the aerogen device is considered on-label for aerogen devices.Recently published studies have reported the use of concurrent aerosol therapy during hfnc using the aerogen solo nebuliser in paediatric patients with asthma.The device was not returned for additional device investigation.Therefore, based on assessments completed to date and in the absence of additional information, no further assumption can be drawn on device function.A root cause cannot be determined but may be attributed to a disconnection between the controller cable and the nebuliser, in which risk assessment has concluded there is adequate instructions, warnings and troubleshooting around amber light display on the controllers and if there is remaining medication found in the nebuliser reservoir.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 aerogen's quality management system.

Event Description

On the (b)(6) 2022, an aerogen employee (clinical support specialist) was notified of an event related to an aerogen device which occurred on the (b)(6) 2022, at (b)(6) ireland, (b)(6), ireland.On becoming aware of the event, the aerogen clinical support specialist notified aerogen customer complaints team.The complaints representative requested additional information from the reporter.The initial reporter provided the following information: "9 yr.Old boy admitted post cardiorespiratory arrest secondary to severe asthmatic attack.Transferred to the ward from picu on (b)(6) 2022 early morning, 05.00.Receiving hhfnc oxygen via airvo 2 - 15l/min and 28% o[?] receiving 4 hrly salbutamol 5mgs and ipratropium bromide 250 mcgs 6 hrly on ward.Had been receiving pulmozyme nebs in picu through ventilator but these were discontinued on (b)(6) 2022 ward nurse administered nebs as prescribed and started nebs, green light visible as reported.Night of (b)(6) 2022 @ 23.00hrs, patient's wob increasing, rr and effort increased, very wheezy on auscultation of chest, o2 desaturations to 85-89%.Reviewed by medical and anaesthetic team, noted that increased fluid in aerogen chamber and alarm button orange.Aerogen set and tubing changed, noted to have 'drug residue' in chamber.Set disposed.Commenced hourly salbutamol nebs via new aerogen solo and administered freely, hhfnc flow increased to 40l/min and fio2 increased to 85%.Patient transferred to picu".In summary, the event is related to use of the aerogen solo nebuliser, on worsening of patient symptoms it was observed by the medical team that there was 'increased fluid' in the aerogen nebuliser chamber and the controller alarm button was orange.The amber alarm on the controller is an error indicator, it is unknown at this time whether a pro x controller or usb controller was utilized in this event with the aerogen solo nebuliser.The mode of use of the controller is not yet known.The initial reporter communicated that aerogen set and tubing were changed and was noted to have 'drug residue' in chamber.On the (b)(6) 2022 the intial reporter confirmed no further information would be provided to aerogen.The device was not returned, location is unknown and was indicated as 'disposed' in initial communications.Patient outcome after the event is unknown at this time.

• Brand Name: AEROGEN SOLO NEBULIZER SYSTEM
• Type of Device: NEBULIZER
• 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: 13861869
• MDR Text Key: 289000217
• Report Number: 3003399703-2022-20976
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K070642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AG-AS3001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2022
• 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: 9 YR
• Patient Sex: Male