MAUDE Adverse Event Report: AEROGEN LTD AEROGEN PRO-X CONTROLLER

Model Number AG-PX1050-US

Device Problem Use of Device Problem (1670)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 06/05/2023

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

Patient was on a servo i with active humidification.Off label medication (veletri) was checked at 0310 in the morning and was functioning appropriately.Doctor came up to the department for lunch after this and around 0330 he saw the lights kind of flicker and assumed it was a generator test/switch over.He was called back down to assess the patient as he had decompensated and saw that the aerogen was off-due to the power failure/generator test.The med was dripping but not nebulizing.He aspirated the med and restarted the pump and aerogen machine and everything was nebulizing correctly.Just to be safe he switched aerogen nebulizers and pulled the other one out of service.Doctor estimated that the patient was off the off label medication for 20 minutes or less.Patient who was already in rv (right ventricular) failure, went into rv failure, and had to be sent back to the or and placed on nitric.Aerogens complaint team are in continued follow up with the initial reported for additional information on the event and requested the device be returned to aerogen for investigation.

Manufacturer Narrative

Aerogen have taken the appropriate measures to review and investigate the complaint received.Aerogen requested further information from the reporting healthcare worker to determine further details on the event and 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.Update on 14th september 2023: follow up report is submitted for the additional information of investigation conclusions completed.The report has been updated for the following fields only and the narrative below: b4, g6 & h2.Aerogen have taken the appropriate measures to review and investigate the complaint received including the following: aerogen requested the device be returned for investigation.The returned device was subjected to visual and functional testing.The device failed testing for a swollen and fatigued battery, in addition to the control module not functioning under battery power when the ac/dc adapter was disconnected.There was no nebulisation under battery power alone.A risk assessment detailed the root cause of this complaint is due to battery fatigue which resulted in swelling.Once the mains supply was interrupted in continuous mode of the controller, the battery did not function correctly, and the controller powered off rather than alternating to intermittent mode.This affected the patient as they were not receiving medication on a continuous basis.The most likely outcome of this based on review of risk documentation is "no or incomplete or prolonged drug delivery", which is an anticipated risk identified by aerogen for devices and has been appraised as part of aerogens, risk management procedure.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.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.A clinical assessment was completed with the following determinations and conclusions: based on the evidence available, it is unclear where the aerogen solo was positioned in the circuit and which cnts delivery settings were employed.Given the clinical status of the patient, it is possible that failure to continuously nebulise veletri (epoprostenol) due to a mains power outage could contribute to the patient impact observed.The delivery of veletri (epoprostenol) using the aerogen solo system by inhalation is considered abnormal use for aerogen devices.The aerogen solo manual contains information related to the use of the device in continuous mode and disconnection/interruption of the mains power including the following: - the continuous mode can only be operated from ac power supply'.- note: if the mains power is disconnected during a continuous nebulisation cycle and reconnected within 10 seconds, the controller shall return to continuous nebulisation mode automatically'.- the rechargeable battery can power the system for up to 45 minutes when fully charged.In the case of ac power failure, the controller will automatically switch to battery operation'.It is unknown how long the mains power was disrupted for, but it appears the device may have switched to battery after the generator test.The device failed for a defective (fatigued) battery and therefore the control module did not function under battery power.Based on the assessments completed to date there are no further actions determined by aerogen at this time and aerogen will continue to monitor complaints received, the occurrance rating and severity of the risk as per aerogens quality management system.

Event Description

Patient was on a servo i with active humidification.Off label medication (veletri) was checked at 0310 in the morning and was functioning appropriately.Doctor came up to the department for lunch after this and around 0330 he saw the lights kind of flicker and assumed it was a generator test/switch over.He was called back down to assess the patient as he had decompensated and saw that the aerogen was off-due to the power failure/generator test.The med was dripping but not nebulizing.He aspirated the med and restarted the pump and aerogen machine and everything was nebulizing correctly.Just to be safe he switched aerogen nebulizers and pulled the other one out of service.Doctor estimated that the patient was off the off label medication for 20 minutes or less.Patient who was already in rv (right ventricular) failure, went into rv failure, and had to be sent back to the or and placed on nitric.Aerogens complaint team are in continued follow up with the initial reported for additional information on the event and requested the device be returned to aerogen for investigation.

Manufacturer Narrative

Aerogen have taken the appropriate measures to review and investigate the complaint received.Aerogen requested further information from the reporting healthcare worker to determine further details on the event and 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.Update on 14th september 2023: follow up report is submitted for the additional information of investigation conclusions completed.Aerogen have taken the appropriate measures to review and investigate the complaint received including the following: aerogen requested the device be returned for investigation.The returned device was subjected to visual and functional testing.The device failed testing for a swollen and fatigued battery, in addition to the control module not functioning under battery power when the ac/dc adapter was disconnected.There was no nebulisation under battery power alone.A risk assessment detailed the root cause of this complaint is due to battery fatigue which resulted in swelling.Once the mains supply was interrupted in continuous mode of the controller, the battery did not function correctly, and the controller powered off rather than alternating to intermittent mode.This affected the patient as they were not receiving medication on a continuous basis.The most likely outcome of this based on review of risk documentation is "no or incomplete or prolonged drug delivery", which is an anticipated risk identified by aerogen for devices and has been appraised as part of aerogens, risk management procedure.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.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.A clinical assessment was completed with the following determinations and conclusions: based on the evidence available, it is unclear where the aerogen solo was positioned in the circuit and which cnts delivery settings were employed.Given the clinical status of the patient, it is possible that failure to continuously nebulise veletri (epoprostenol) due to a mains power outage could contribute to the patient impact observed.The delivery of veletri (epoprostenol) using the aerogen solo system by inhalation is considered abnormal use for aerogen devices.The aerogen solo manual contains information related to the use of the device in continuous mode and disconnection/interruption of the mains power including the following: the continuous mode can only be operated from ac power supply'.Note: if the mains power is disconnected during a continuous nebulisation cycle and reconnected within 10 seconds, the controller shall return to continuous nebulisation mode automatically'.The rechargeable battery can power the system for up to 45 minutes when fully charged.In the case of ac power failure, the controller will automatically switch to battery operation'.It is unknown how long the mains power was disrupted for, but it appears the device may have switched to battery after the generator test.The device failed for a defective (fatigued) battery and therefore the control module did not function under battery power.Based on the assessments completed to date there are no further actions determined by aerogen at this time and aerogen will continue to monitor complaints received, the occurrance rating and severity of the risk as per aerogens quality management system.Update on the 12th of january: follow up report 2 submitted for the addition of 510k number.

Event Description

Patient was on a servo i with active humidification.Off label medication (veletri) was checked at 0310 in the morning and was functioning appropriately.Doctor came up to the department for lunch after this and around 0330 he saw the lights kind of flicker and assumed it was a generator test/switch over.He was called back down to assess the patient as he had decompensated and saw that the aerogen was off-due to the power failure/generator test.The med was dripping but not nebulizing.He aspirated the med and restarted the pump and aerogen machine and everything was nebulizing correctly.Just to be safe he switched aerogen nebulizers and pulled the other one out of service.Doctor estimated that the patient was off the off label medication for 20 minutes or less.Patient who was already in rv (right ventricular) failure, went into rv failure, and had to be sent back to the or and placed on nitric.Aerogens complaint team are in continued follow up with the initial reported for additional information on the event and requested the device be returned to aerogen for investigation.

• Brand Name: AEROGEN PRO-X CONTROLLER
• Type of Device: AEROGEN PRO-X CONTROLLER
• 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: andrea small ; galway business park; dangan; galway, H91EH-6C ; EI H91EH6C
• MDR Report Key: 17315768
• MDR Text Key: 318941327
• Report Number: 3003399703-2023-21751
• 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

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AG-PX1050-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: No
• 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