MAUDE Adverse Event Report: AEROGEN LIMITED AEROGEN PRO X AEROGEN SOLO NEBULIZER SYSTEM; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number AG-AS300

Patient Problem High Pulmonary Arterial Wedge Pressure (2480)

Event Date 07/24/2023

Event Type  malfunction  

Event Description

The device failed to nebulize epoprostenol medication shortly after it was initiated.Multiple attempts to flush the nebulizer and restart medication were unsuccessful.The device would briefly resume nebulizing the medication, but only for short periods of time.This led to an increase in the patient's pulmonary artery (pa) pressures.Of note-this pump does not have an alarm when a patient is not being nebulized to alert staff.If the pump would have an alarm, staff would be notified when it is not nebulizing.

• Brand Name: AEROGEN PRO X AEROGEN SOLO NEBULIZER SYSTEM
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): AEROGEN LIMITED; 14080 sw 139 ct; miami FL 33186
• MDR Report Key: 17755157
• MDR Text Key: 323498778
• Report Number: 17755157
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AG-AS300
• Device Catalogue Number: AG-AS300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male