MAUDE Adverse Event Report: MINNETRONIX TYVASO INHALATION SYSTEM; NEBULIZER

Model Number TD-100/A

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907); Tachycardia (2095); Hot Flashes/Flushes (2153); Dizziness (2194)

Event Type  Injury  

Event Description

Tired.Heart racing.This case is a spontaneous report from the united states received from a consumer via a speciality pharmacy.The patient was a (b)(6) female who first received tyvaso (treprostinil sodium) via inhalation (ih) on (b)(6) 2014 for secondary pulmonary hypertension.Inhaled (ih)treprotinil dose was 18-54 micrograms (3-9 breaths), four times a day at the time of the events.Suspect product was delivered via tyvaso inhalation system, device model td-100 a, serial number (b)(4).Patient reported problems with device (sn# (b)(4)).When patient re=started device for treatment, it appeared to be "spinning all the time" and patient further stated "feels may have gotten too much medication" which resulted in the patient experiencing unfavorable adverse event(s).Reported headache, flushed, felt warm dizzy and heart racing.Went and laid down for 2 hours and "feels better but still very tired.Action taken with the ih treprostinil due to the events of tired, heart racing, felt dizzy, headache, flushing was not reported.The devices were replaced.Manufacturer report number (b)(4).The investigation is ongoing at the time of this submission.The case is submitted in the abundance of caution.

• Brand Name: TYVASO INHALATION SYSTEM
• Type of Device: NEBULIZER
• Manufacturer (Section D): MINNETRONIX; st. paul MN
• MDR Report Key: 4834754
• MDR Text Key: 16987666
• Report Number: MW5042996
• Device Sequence Number: 1
• Product Code: CAF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• 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?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LOT 2101541, EXP DATE 04/30/2016; RYVASO INHALATION GAS, 0.6 MG/ML, 18-54 MCG
• Patient Age: 41 YR
• Patient Weight: 47