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

Device Problems Use of Device Problem (1670); Patient Device Interaction Problem (4001)

Patient Problem Urinary Frequency (2275)

Event Type  malfunction  

Event Description

Concerns with treprostinil (tyvaso) administration using patient's own nebulizer in the inpatient setting.Patient involved is a 65-year-old male who initially presented on "x/xx" to the institution for a complaint of diuresis.Patient's relevant medical history is significant for pulmonary hypertension which is being treated with inhaled treprostinil (tyvaso) and tadalafil.Once admitted, the prescribed dose for the tyvaso was 0.036 mg (6 puffs) 4 times daily.The product used was the inhaled 1.74 mg/2.9 ml nebulizer solution and the tyvaso inhalation system, which consists of the optineb-ir model on-1oon provided by united therapeutics through specialty pharmacies.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.There is an institutional kit that is offered by the manufacturer that contains 2 nebulizers, however it can only be used for patients starting on treprostinil, not for patients already on treprostinil.Therefore, there are three potential errors that present with this patient.This patient was compliant in bringing their nebulizer, however nursing staff and rts both voiced concerns about the patient self-administering the treprostinil using their own supply of treprostinil and nebulizer.This runs the risk of patient supply running out upon discharge as the specialty pharmacy will not dispense medication to the patient when they are admitted.Current hospital policy states that tyvaso is only to be administered by the respiratory tech.In the case of this patient, they are self-administering the medication the same way they have done in past administrations and refusing education/observation by the rt.Some of these administrations are witnessed by the nurse, sometimes they forget a dose and at other times, the patient is self-administering the medication with their spouse as the witness to the administration.Without rt observation, the correct technique cannot be verified by the staff and the safety of the home medication and machine cannot be verified.From an infection prevention standpoint, most nebulizers are replaced at the end of the day by the rt according to hospital policy.However, with this specialized nebulizer, the rt must remember to clean the machine with mild water and soap and discard filters to set it up for the next set of treatments.A simpler method would be to just replace the nebulizer.Allow inpatient hospitals to purchase and obtain the tyvaso delivery system to keep within the hospital to administer to incoming patients currently on tyvaso.Educate the patient on the importance of having an rt present to assess technique upon administration of an inhaled solution.Educate the patient on why the hospital limits the use of the patient's own medication and the safety implications of why the hospital switches to medications on their formulary during their inpatient stay.Educate the rt on cleaning of the specialized nebulizer and the importance of ensuring that the cleaning is done at the end of a treatment session to maintain infection control parameters.(b)(4).

• Brand Name: NEBULIZER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• MDR Report Key: 15380793
• MDR Text Key: 299770187
• Report Number: MW5111937
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• 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: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: TADALAFIL; TREPROSTINIL SODIUM
• Patient Sex: Male