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

Device Problem Insufficient Information (3190)

Patient Problem Urinary Frequency (2275)

Event Date 06/22/2022

Event Description

Currently, united therapeutics does not sell the nebulizer as a stand-alone product for purchase by hospitals.Therefore, we rely on the patient to bring their nebulizer upon admission.Patient involved is a 65-year-old male who initially presented on 6/21 to the institution for a complaint of diuresis.The patient's relevant medical history is significant for pulmonary hypertension which is being treated with inhaled treprostinil (tyvaso) 0.036 mg (6 puffs) 4 times daily.The product that is used is the inhaled 1.74 mg/2.9 ml nebulizer solution which is manufactured by united therapeutics.There are three potential errors that present with this patient.First, this patient is self-administering the treprostinil using their own home supply of treprostinil and nebulizer.The patient, therefore, runs the risk of running out of supply upon discharge as the specialty pharmacy that provides the medication will not dispense medication to the patient when they are admitted.Second, current hospital policy states that tyvaso is only to be administered by the respiratory tech (rt) and this patient refuses education/observation by the rt citing the reason for refusal as experience from past self-administrations have been adequate.Third, from an infection prevention standpoint, most nebulizers are replaced at the end of the day by the rt, or in this case, the patient or staff must clean the machine with mild water and soap and discard filters.What should be happening to resolve this is the patient should be receiving hospital-provided treprostinil and nebulizer to better document administrations on the mar.Rt should be present to view this administration and educate the patient on the proper use of products and answer questions which is within the hospital policy, so the patient's refusals should be addressed.The rt should be given the responsibility to clean the nebulizer and to help prepare for the following day's administration or the manufacturer should be providing replacement nebulizers."optineb-ir model on-100/7." fda safety report id # (b)(4).

• Brand Name: NEBULIZER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• MDR Report Key: 15079601
• MDR Text Key: 296469714
• Report Number: MW5111046
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White