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

Device Problem Display or Visual Feedback Problem (1184)

Patient Problems Bradycardia (1751); Pneumonia (2011); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Spontaneous call from patient who reported about 5 days ago, one of her td300 devices alarmed with error stating water was needed.She looked inside and said it was already filled with water so she ended up switching to her backup device.That is the first time she ever experienced that problem with the device.Patient also reported being in the intensive care unit for about 7 days a few weeks ago due to pneumonia and bronchitis.She denied any changes in her breathing once she recovered from her illness.Patient is feeling better now.She also reported that her tongue "feel pitted" and stated this is something that has been going on for a while now.Unknown if her doctor is aware of all these events.Did the pt have a backup device they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes; is the infusion life sustaining? yes; what is the outcome of the event? resolved.Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual device available for investigation? yes; did we [mfr] replace the device? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: TYVASO INHALATION SYSTEM TD300
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): UNITED THERAPEUTICS CORPORATION; 1040 spring street; silver spring MD 20910
• MDR Report Key: 14854289
• MDR Text Key: 295041028
• Report Number: MW5110566
• 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: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• 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
• Treatment: REVATIO 20 MG
• Patient Sex: Female