MAUDE Adverse Event Report: AEROGEN LTD. AEROGEN NEBULIZER ; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problems Improper or Incorrect Procedure or Method (2017); Improper Flow or Infusion (2954)

Patient Problem Right Ventricular Dysfunction (2054)

Event Date 08/29/2018

Event Type  Injury  

Event Description

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-of 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 mins rather than continuous flow - thought to be due to a temporary unplugging of the device, which then resulted in the device reverting to 30 mins 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 the 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.

• Brand Name: AEROGEN NEBULIZER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): AEROGEN LTD.; chicago IL
• MDR Report Key: 8662479
• MDR Text Key: 147015241
• Report Number: MW5087086
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 55