MAUDE Adverse Event Report: AEROGEN LTD AERONEB PRO-X; NEBULIZER

Model Number AG-AS3000

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Deliver (2338)

Patient Problems Low Oxygen Saturation (2477); No Code Available (3191)

Event Date 06/27/2017

Event Type  Injury  

Manufacturer Narrative

Device details and/or patient details have not been identified in the user facility report; as well as device was not provided to the manufacturer.

Event Description

According to the event description provided by the user facility: "product stopped delivering the continuous nebulization of epoprostenol for unknown reason.Dose or amount: 40 ng/kg/min nitric oxide.Frequency: continuous, route: inhalation.Dates of use: (b) (6) 2017.Diagnosis or reason for use: pulmonary hypertension.Is the product compounded: no.Is the product over-the-counter: no".

Manufacturer Narrative

Information provided in the initial mnf report # 3003399703-2017-00001: device details and/or patient details have not been identified in the user facility report; as well as device was not provided to the manufacturer.The following additional information was received on the 26th october 2017 and added in the applicable sections throughout this report: patient details: male of unknown ethnicity, (b)(6) old at the time of incident; device details: device is not available for return as it was not sequestered in time; lot number is not available also; patient outcome details: desaturation (lack of adequate tissue oxygenation); event details: patient was receiving two therapies at the time of incident - 40ng/kg/min flolan continuous inhalation and 40 ppm nitric oxide therapy for pulmonary hypertension phtn.During the procedure patient experienced a significant drop of oxygenation (spo2 dropped to the 60's) which impacted patient's ability to keep adequate oxygenation to the tissue secondary to a sudden therapy interruption, when nebuliser failed to deliver the medication continuously.Patient had to be taken off the ventilator.He was manually ventilated with ambu bag and the oxygenation issue improved.Corrected data: (b)(4).Conclusion: the device was not returned by the user facility, therefore actual device evaluation could not be conducted.Following completion of aerogen qf179 product failure investigation form (non returned devices) failure mode and a root cause were identified as not determined.In addition, description of the event references the use of flolan (epoprostenol sodium) drug for inhalation.According to the fda drug database: fda approved drug products - flolan (epoprostenol sodium) is delivered via injection route.Therefore it is not a drug approved for inhalation and therefore its use falls outside the scope of the intended use of the aerogen solo nebuliser.[aerogen solo nebuliser is intended for hospital use to nebulise physician-prescribed medications for inhalation which are approved for use with a general purpose nebuliser].Due to the fact that the use of epoprostenol is not covered within the intended use of the aerogen solo system, aerogen does not have any data associated with the performance characteristics of the device in this application, as well as this application is not addressed in aerogen's risk management processes.Therefore when the device is being used outside of its intended use the device may not function as intended; hence it is being used at the users risk.Therefore, from the information supplied to-date, there is no evidence present to indicate that device malfunction occurred in this instance.Should this become available at a later date, this complaint will be re-opened and updated accordingly and a follow up mdr will be submitted to the fda, if deemed relevant.We will continue to monitor for these complaint types.

Event Description

According to mnf report # 3003399703-2017-00001, submitted on the 21st september 2017, event description provided by the user facility is as follows: "product stopped delivering the continuous nebulization of epoprostenol for unknown reason.Dose or amount: 40ng/kg/min nitric oxide.Frequency: continuous, route: inhalation.Dates of use: (b)(6) 2017.Diagnosis or reason for use: pulmonary hypertension.Is the product compounded: no.Is the product over-the-counter: no".

• Brand Name: AERONEB PRO-X
• Type of Device: NEBULIZER
• Manufacturer (Section D): AEROGEN LTD; galway business park; dangan; galway, H91 H E94; EI H91 HE94
• Manufacturer Contact: iryna barouskaya ; galway business park; dangan; galway, galway H91 H-E94 ; EI H91 HE94
• MDR Report Key: 6882696
• MDR Text Key: 87169133
• Report Number: 3003399703-2017-00001
• 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: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: AG-AS3000
• Device Catalogue Number: NOT PROVIDED
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2017
• 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; Required Intervention
• Patient Age: 2 MO