MAUDE Adverse Event Report: UNITED THERAPEUTICS TYVASO INHALATION SYSTEM

Model Number TD-100/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Dizziness (2194); No Code Available (3191)

Event Type  Injury  

Event Description

Pump bubbles all the time with pause when you breathe [device - malfunction].Bitter taste in mouth [taste bitter].Dizziness [cough].Case description: this case is a spontaneous report from the united states regarding a report received from a consumer via a specialty pharmacy.Add'l info was received from the pt on (b)(6) 2014.Add'l info was received on (b)(6) 2014.The pt was a (b)(6) female of unk height and race who first received tyvaso (treprostinil) on (b)(6) 2013 for primary pulmonary hypertension.Inhaled (ih) treprostinil dose was 18-54 micrograms (3-9 breaths), four times daily (qid) at the time of the event.The pt reported that one pump did not work (td100 or td100 a with serial numbers (b)(4) or (b)(4) respectively) and it bubbled all the time, without a pause when she took a breath.The pt also noted that she felt dizzy after 4-5 puffs, like she got too much medication.She switched to other pump, which functioned as expected, and noted no dizziness.She tried the first pump again, and the pump issues reoccurred with quick dizziness and increased cough.The pt also had a bitter taste in mouth after each time this happened.The td100 device was replaced.The outcomes of the events of bitter taste in mouth, dizziness, cough and pump bubbles all the time with pause when you breathe unk.Diagnosis for use: primary pulmonary hypertension (pulmonary arterial hypertension).

• Brand Name: TYVASO INHALATION SYSTEM
• Type of Device: TYVASO INHALATION SYSTEM
• Manufacturer (Section D): UNITED THERAPEUTICS
• MDR Report Key: 4443261
• MDR Text Key: 5379818
• Report Number: MW5040330
• 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: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TD-100/A
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 18-54 MICROGRAMS, QID, INHALATION:; LOT #2100387, EXP: 07/31/2015; 0.6MG/ML; TRACLEER/01587724 (BOSENTAN); TYVASO (TREPROSTINIL SODIUM) INHALATION GAS,
• Patient Age: 68 YR
• Patient Weight: 80