MAUDE Adverse Event Report: UNITED THERAPEUTICS CORPORATION TD300 TYVASO INHALATION SYSTEM; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problems Break (1069); Output Problem (3005)

Patient Problems Headache (1880); Low Blood Pressure/ Hypotension (1914); Sore Throat (2396); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Patient reported that she has been hospitalized as of (b)(6) 2023 for complications related to her pulmonary arterial hypertension.Patient was in the intensive care unit (for about 2 weeks) when one of her nebulizers stopped working.A pharmacist advised her to use her backup and call cvs when she was feeling better to report the malfunction.Patient reported that she is on the pulmonary transplant unit and the nurses there were assisting her with the tyvaso nebulizer.One of the nurses reported to the patient that the nebulizer stopped working and that they were unable to charge it because the part on the device for charging had broken off.Patient does not have the malfunctioned device and does not know where it is since she was recently moved from the intensive care unit to another floor.Unk if it's user error.Pt has been experiencing headaches, sore throat, fluid overload, and hypotension, unk if doctor (b)(6) is aware but there is a team managing her therapy while in pt.Length of hospitalization is ongoing.Anticipated discharge date not specified; tyvaso nebulizer pt.The suspect device serial number was not provided by the pt.Per the pharmacy dispensing system, the following device serial numbers are currently checked out by the pt; for use: (b)(6) no due dates available.Pt is actively taking tyvaso and adcirca.Reported to cvs/caremark by pt/caregiver.

• Brand Name: TD300 TYVASO INHALATION SYSTEM
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): UNITED THERAPEUTICS CORPORATION
• MDR Report Key: 17217888
• MDR Text Key: 318138240
• Report Number: MW5118874
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female