MAUDE Adverse Event Report: TYVASO INHALATION SYSTEM - NEBULIZER

Model Number TD-100/A

Device Problems Output above Specifications (1432); Inaccurate Delivery (2339); Device Operates Differently Than Expected (2913)

Patient Problems Headache (1880); Overdose (1988)

Event Type  Injury  

Event Description

Device continues to produce vapor [device issue].Received too much medication [incorrect dose administered by device].Lightheadedness.Case description: this case is a spontaneous report from the united states received from a consumer via a specialty pharmacy on 03/02/2016.The patient was a (b)(6), (b)(6), male of unreported height and race, who first received tyvaso (treprostinil) via inhalation route on (b)(6) 2015 for secondary pulmonary hypertension.Inhaled (ih) treprostinil dosage was 18-54 micrograms (3-9 breaths), four times a day, at the time of the events.Inhaled treprostinil was delivered via tyvaso inhalation system, model td-100/a, serial number (b)(4).The patient was on the following concomitant medications at the time of the events: sildenafil and letairis (ambrisentan).On an unspecified date in 2016, the patient's device produced vapor/mist even when the patient was not inhaling, which lead to the patient receiving too much medication.Approximately 30 minutes post treatment, the patient had lightheadedness which lasted for about an hour and then abated.The patient felt much better when he used an alternate device.Patient reports device was continuously producing vapor/mist causing the patient to receive too much drug output.The specialty pharmacy confirmed the devices were replaced.The investigation is incomplete at the time of this report.Mfr name, city and state: (b)(4).Initial reporter: name, address and telephone number withheld.Device manufacture date: 07/2014.Mfr#: (b)(4).

• Brand Name: TYVASO INHALATION SYSTEM - NEBULIZER
• Type of Device: NEBULIZER
• MDR Report Key: 5553784
• MDR Text Key: 42211969
• Report Number: MW5061523
• Device Sequence Number: 1
• Product Code: CAF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TD-100/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 68