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

Device Problems Contamination (1120); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Other  

Event Description

This is a potential error that we have identified at (b)(6) with inhaled epoprostenol.Per (b)(4) guidelines, respiratory medications for inhalation should be prepared in a sterile syringe.We have identified that the aerogen syringe for the aerogen solo continuous nebulization system is not sterile.In order for the pharmacy to prepare and dispense inhaled epoprostenol, the pharmacy would have to prepare the inhaled epoprostenol in an intravenous syringe, and then either the tubing would have to be configured to accommodate an iv syringe, or the product would have to be transferred to the aerogen syringe at the bedside for immediate use.The iv bo syringes are not compatible with the aerogen pump.This gap of dispensing in an iv syringe leaves room for error and accidental administration via iv.We have two possible short term strategies that have been proposed, but there is still a chance for error when pharmacy is dispensing in the iv syringe.Dispense the product in a bd iv syringe along with an empty aerogen syringe, the respiratory therapist would transfer the medication to the aeorgen syringe for immediate use.Products would be labeled for inhalation only.Attaching an example from an ashp forum post.Dispense the product in a bd iv syringe, and education on how to attach the iv syringe to the nebulization syringe.The best solution would be for the manufacturer to provide a sterile syringe.(b)(6).Submission id: (b)(4).

• Brand Name: AEROGEN SYRINGE
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): AEROGEN LTD.
• MDR Report Key: 17079326
• MDR Text Key: 316756452
• Report Number: MW5118215
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1