MAUDE Adverse Event Report: AEROGEN LTD AEROGEN PROFESSIONAL NEBULIZER SYSTEM

Device Problems Off-Label Use (1494); Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Low Oxygen Saturation (2477)

Event Date 03/13/2021

Event Type  Injury  

Manufacturer Narrative

On 19th may 2021, aerogen were notified of an incident via the us agent emergo for a medwatch report (mw5100176) from fda.The event which occurred on the (b)(6) 2021, was reported to fda in march 2021 by the initial reporter.The aerogen pro-x controller is mentioned within the event description.Upon further communication with the initial reporter, it transpired that the aerogen pro-x controller was utilized with the aerogen solo nebulizer for continuous delivery of medication for inhalation.Additional information was provided by the initial reporter that the event was related to the medication not nebulized as the vibrating mesh within the solo nebulizer appeared 'clogged'.Upon replacement of the cable, continuous nebulisation resumed.The pro-x controller continued to be used.With the additional information it can be concluded that the controller has not malfunctioned.The device is not available for return.The lot number is not available.Description of the event references the use of flolan which contains active ingredients of epoprostenol sodium and is a drug to be delivered via injection route.According to the fda drug database: fda approved drug products - flolan 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.Hence use of the flolan constitutes a user error, i.E., the device was used off-label.As per device instructions for use manual, the intended use within the hospital environment states 'it is intended for hospital use only to nebulize physician-prescribed medications for inhalation which are approved for use with a general purpose nebulizer'.In addition, the hospital reported a product problem in that aerogen pro-x controller does not include an audible alarm to inform of the instances when the device stops nebulizing.With regard to the alarm issue, an audible alarm is currently not a feature of the controller.According to fda 21 cfr 803.3 (o), mdr reportable event (or reportable event) means: (2) an event that manufacturers or reporters become aware of that reasonably suggests that one of their marketed devices: may have caused or contributed to a death or serious injury; or has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.Based on the fact that 'other serious' injury was reported, aerogen determined that the occurred event is an mdr reportable adverse event.Due to the fact that the device is not available to be returned for investigation, and the above stated off-label use of the device, it can be ascertained that investigation is due to be closed as a non-return, off-label use and no further conclusions can be drawn regarding the root cause of the event.Should the aforementioned preposition change by the time the complaint is officially closed, the new and/or additional information will be submitted to the fda if deemed necessary.

Event Description

Patient on continuous flolan via aerogen nebulizer for pphn.The cord connecting the nebulized medication cup to the machine stopped working, resulting in the flolan not being delivered to the patient for approximately 1.5 hrs.The patient began to desaturate, had increased hr, required more medications, and increased ventilator support.The cord was replaced, the medication began nebulizing again and the patient began to recover without any more interventions, leading me to believe that was what caused the problem in the first place.When the flolan stops nebulizing, there is no way for it to alarm to notify staff.Currently rt check the flolan o2 to make sure it is nebulizing, but it is very difficult to see and can be easily missed.If there was another way for the machine to actually alarm at us when it stops nebulizing, i think that would be more accountable.

• Brand Name: AEROGEN PROFESSIONAL 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, H91 E-H6C ; EI H91 EH6C
• MDR Report Key: 12023471
• MDR Text Key: 263243014
• Report Number: 3003399703-2021-20532
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other