MAUDE Adverse Event Report: UNITED THERAPEUTICS TYVASO INHALATION SYSTEM

Model Number ON-100-HPA

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Fumes or Vapors (2529)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

Burnt abdomen [burn].Battery pack over heated, toxic, electrical, bad smell [device issue].Case description: this case is a solicited report from the united states regarding a report received from a pt via a specialty pharmacy.The pt was a (b)(6) female who first received tyvaso (treprostinil) on (b)(6) 2010 for primary pulmonary hypertension.Inhaled (ih) treprostinil dosage was 72 micrograms (12 breaths), four times daily at the time of the event.Concomitant medication included adcirca (tadalafil) and tracleer (bosentan).During pt's monthly assessment, she reported that she had problems with her treprostinil battery packs.On an unreported date in 2014, the battery packs were over heated due to which her shirt and abdomen was burnt.Pt stated that she did not require any medical attention, or any scaring or marks left behind due to burn.Pt reported that she had stopped using the battery pack.Pt stated that the battery pack had a toxic, electrical, bad smell.The pt was unable to provide serial number for the battery as the battery was among 5 other battery packs which were not working.Pt provided the serial numbers for the battery packs as (b)(4).Pt was advised that the batteries may need to be returned and that she was told to keep batteries until she was instructed to return them.Pt was asked to review the proper use of battery packs, devices and medication administration and the pt verbalized understanding.Ih treprostinil dose was not changed due to the event of burnt abdomen.The reporter did not assess the causal relationship between ih treprostinil and the burnt abdomen.The outcome of the event burnt abdomen: resolved.The outcome of battery pack over heated, toxic, electrical, bad smell and burnt abdomen: unk.Address: united states, name and address withheld.Device manufacture date: 05/2014.

• Brand Name: TYVASO INHALATION SYSTEM
• Type of Device: INHALATION SYSTEM
• Manufacturer (Section D): UNITED THERAPEUTICS
• MDR Report Key: 3944667
• MDR Text Key: 18541546
• Report Number: MW5037290
• 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: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ON-100-HPA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADCIRCA (TADALAFIL) UNK; TYVASO (PREPROSTINIL SODIUM) INHALATION GAS,; TRACLEER (BOSENTAN) UNK; 0.6MG/ML, 72 UG, QID, INHALATION
• Patient Age: 46 YR