MAUDE Adverse Event Report: UNITED THERAPEUTICS TYVASO INHALATION SYSTEM; BATTERY PACK, AC WALL PLUG

Model Number ON-110HPA, ON-100N

Device Problem Battery Problem (2885)

Patient Problems Chest Pain (1776); Dyspnea (1816); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Patient stopped therapy; four to five days without medication (therapy cessation).Out of breath and having difficulty walking (dyspnoea).Chest discomfort.Case description: this case is a spontaneous report from the united states received from a consumer via a patient assistance program and specialty pharmacy on 01 july 2015.The patient was a (b)(6) female of unknown height and race who first received tyvaso (trepostinil sodium) via inhalation route on (b)(6) 2014 for primary pulmonary hypertension.Inhaled (ih) treprostinil dosage was 24 micrograms (mcg) (4 breaths), four times daily, at the time of the events.Inhaled treprostinil was delivered via tyvaso inhalation system, model number on-110 hpa, on-100 n.The patient also first received orenitram (treprostinil diethanolamine) via oral route on (b)(6) 2015 for primary pulmonary hypertension.Oral treprostinil dosage was 0.5 mg twice daily at the time of the events.On (b)(6) 2015, the patient missed dosages of ih treprostinil for a few days, and on an unknown date in 2015, was feeling out of breath, was having difficulty walking, and was also experiencing mild chest discomfort.Patient reports being off her ih treprostinil for several days because she was unable to charge her battery pack and ac wall plug.A new battery pack and ac wall plug were shipped overnight as soon as ut became aware.The specialty pharmacy confirms the patient has two working devices functioning as intended.(b)(4).Device manufacturer date: unk.Diagnosis for use: primary pulmonary hypertension (pulmonary arterial hypertension).Primary pulmonary hypertension (pulmonary arterial hypertension).

• Brand Name: TYVASO INHALATION SYSTEM
• Type of Device: BATTERY PACK, AC WALL PLUG
• Manufacturer (Section D): UNITED THERAPEUTICS
• MDR Report Key: 5001268
• MDR Text Key: 23099544
• Report Number: MW5055329
• 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
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ON-110HPA, ON-100N
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 0.25MG, 0.5MG, BID, ORAL, LOT #2100369,
• Patient Age: 26 YR
• Patient Weight: 95