MAUDE Adverse Event Report: AEROGEN LIMITED AEROGEN SOLO CONTINUOUS NEBULIZATION TUBE SET; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 90-066

Device Problems Product Quality Problem (1506); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2021

Event Type  malfunction  

Event Description

Sbar: aerogen continuous inhalation medication delivery situation.Since (b)(6) of 2020 we have been placed on allocation for aerogen syringes due to covid-19.We have also had problems with the proprietary tubing from aerogen, as it is sometimes too long causing it to rest on the mesh and impeded nebulization.Background: (b)(6) of 2017, we were informed that aerogen solo luer connector was no longer going to be produced after (b)(6) 2017.We were given two options: we could go to a syringe pump system or a cme pump system.We decided on the cme method because we could continue to use the iv bags with the addition of the fused luer tubing.Additionally, the aerogen syringe is not sterile and cannot go under the pharmacy hood for compounding medication.(b)(6) 2019, we started using the cme pump.(b)(6) 2020, we were notified that cme pumps were recalled, forcing us to go to the syringe pump delivery system.(b)(6) 2020, we went back to using the single luer and the sigma spectrum pump until we could develop education and obtain syringe pumps.On (b)(6) 2021 we rolled out the medfusion syringe pump.That day respiratory care leads were made aware of the allocation that tri-anim had placed us on.That allocation was for 15 syringes a month.This was based on our other facility's usage since we had not started with the syringe pump yet.(b)(6) 2021, we reached out to get allocation increased to no avail.(b)(6) 2021, allotment was increased to 200 syringes a month.Assessment: current state we may or may not have enough syringe allotment for our hospitals' needs.If we look at our usage over the last six months, we would have averaged 268 syringes per month.Aerogen is the only device on the market that allows for medications to be aerosolized throughout the lung while not adding any additional flow to the patient's vent circuit.Because of their monopoly on this market; we are tied to using their proprietary supplies for delivery.Recommendation: we have developed a way utilizing non-proprietary iv tubing and a spike for delivering continuous nebulization using the aerogen nebulizers.We would not have to use their syringe or feedline with luer.Which would alleviate the continued issues we have with allocation as well as disposables failure.

• Brand Name: AEROGEN SOLO CONTINUOUS NEBULIZATION TUBE SET
• 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: 11796681
• MDR Text Key: 249704575
• Report Number: 11796681
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 90-066
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1