MAUDE Adverse Event Report: AEROGEN LIMITED AEROGEN PROFESSIONAL NEBULIZER SYSTEM; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 10-059

Device Problems No Audible Alarm (1019); Communication or Transmission Problem (2896); Output Problem (3005)

Patient Problem Respiratory Insufficiency (4462)

Event Date 10/27/2020

Event Type  malfunction  

Event Description

Upon arrival into icu patient's room, the aerosol medication administration was not running.The yellow light was showing on the aerogen pro-x controller.Six cc of the aerosol medication were removed from the solo cup.The infusion pump was running at approximately 4 cc per hour.Thus, the aerosol medication was not running for at least 1.5 hours.Patient's pa pressure noted to be in the high 60's.And approximately 1 hour later the patient's pa pressure's in the 30's.We had multiple issues arising from (b)(6) 2018 through (b)(6) 2020.Some of these issues were addressed but we continue to request an audible alarm from the manufacturer.When the controller senses that the cable is not communicating, a bright yellow light turns on.There is no complimentary audible alarm.Many times, an rrt or rn will not notice this light until the patient begins to clinically decompensate.Upon trouble shooting and system check, the clinician finds the nebulizer cup full.(the infusion pump continues to administer the med, yet the nebulizer has stopped working because there is no cable communication with the controller.) we have also been told repeatedly by the company that this would be a huge endeavor to have approved by the fda, but we have not received any updates or information regarding whether they will create this alarm to avoid future disruption of continuous nebulized medications.

• Brand Name: AEROGEN PROFESSIONAL NEBULIZER SYSTEM
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): AEROGEN LIMITED; 2500 bee cave road; bldg 1, suite 300; austin TX 78746
• MDR Report Key: 10800387
• MDR Text Key: 215067749
• Report Number: 10800387
• 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: 11/02/2020,10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10-059
• 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: 11/02/2020
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18615 DA
• Patient Weight: 102