MAUDE Adverse Event Report: AEROGEN LIMITED AEROGEN; AEROGEN NEBULISER

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Defective Component (2292)

Patient Problems Hemorrhage/Bleeding (1888); No Code Available (3191)

Event Date 08/29/2018

Event Type  Injury  

Manufacturer Narrative

Information regarding patient details has not been identified in the sus voluntary event report [mw5087086], therefore it has been requested.Investigation of the incident is being carried out.The conclusion on same will be provided in the follow up report.

Event Description

According to the event description provided in the sus voluntary event report [mw5087086]: "we do not think the device was defective.This is a voluntary report to make a request to the company to consider developing a safety enhancement.Pt transferred to our icu on (b)(6) 2018 from an outside hosp following va ecmo cannulation when unable to wean off cpb after avr/mvr/cab.The pt had acute circulatory decompensation with concern for intrathoracic bleeding.Pt was on epoprostenol via aerogen nebulizer in our icu.On (b)(6) 2018, the pt went to the operating room for a second wash-out procedure.After transfer to the operating room and hand-off report regarding the epoprostenol from respiratory therapist to anesthesia provider.At the end of the procedure, the pt was weaned from ecmo and the aorta and right atrium were decannulated.The cannulation sites were secured.The sternum was closed.The pt did not tolerate this and, so the sternum was reopened.Right ventricular dysfunction was noted and the pt was started on inhaled nitric oxide with much improvement hemodynamically and returned to the icu.It was then discovered that the epoprostenol was not nebulizing, as the setting was on 30 min rather than continuous flow - thought to be due to a temporary unplugging of the device, which then resulted in the device reverting to 30 min rather than continuous flow.Since this event, our organization has provided education to anesthesia providers regarding use of the aerogen nebulizer, including the fact that unplugging the device will cause it to the 30-min setting.Note: we ask company to consider developing an alarm system that will alert caregivers whenever the flow of medication is interrupted, causing a change in the flow setting.Not considered defective or suspect".

Manufacturer Narrative

1) information provided in the initial mfr report # 3003399703-2019-00001: information regarding patient details has not been identified in the sus voluntary event report [mw 5087086], therefore it has been requested.Investigation of the incident is being carried out.The conclusion on same will be provided in the follow up report.2) the following information was ommitted in the initial report and is being added now: section g4: date received by manufacturer is updated to include 18th june 2019.3) additional data: ·patient code(s): 3191 no code available; ·device code(s): 1494 off-label use; 2017 improper or incorrect procedure or method; ·method code(s): 4114 device not returned; ·result code(s): 3221 no findings available; ·conclusion code(s): 67 no problem detected.4) conclusion: the event description reveals two instances of the user error occurrences: 1) use of the epoprostenol constitutes a user error.According to the fda drug database: fda approved drug products - epoprostenol 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.2) there was a temporary unplugging of the device, which would also be considered a user error - as the instructions stipulated in the instruction manual were not followed.According to the aerogen solo system instruction manual 30-354, rev s: 'if the mains power is disconnected during a continuous nebulisation cycle and reconnected within 10 seconds, the controller shall return to continuous nebulization mode automatically'.Aerogen ltd.Confirms the initially identified scope of the mdr being an adverse event.Due to the fact that device was not returned for investigation, investigation was closed as a non-return and no further conclusions could be drawn regarding the failure mode and root cause of the event.Should additional information become available at any point, this complaint will be re-opened, and additional information will be submitted to the fda if deemed necessary.

Event Description

No additional information available to what was provided in the initial report.

• Brand Name: AEROGEN
• Type of Device: AEROGEN NEBULISER
• Manufacturer (Section D): AEROGEN LIMITED; galway business park; dangan; galway, H91 H E94; EI H91 HE94
• MDR Report Key: 8803001
• MDR Text Key: 151456855
• Report Number: 3003399703-2019-00001
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K070642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening