MAUDE Adverse Event Report: UNITED THERAPEUTICS TYVASO INHALATION SYSTEM; NONE

Model Number TD-100 / A

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Smoking (1585); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2014

Event Type  malfunction  

Event Description

Base started smoking [device issue].Case description: this case is a spontaneous report from the united states regarding a report received from a consumer via a specialty pharmacy.The patient was a (b)(6), female of unknown height and race who first received tyvaso (treprostinil) on (b)(6) 2013 via inhalation for primary pulmonary hypertension.Inhaled treprostinil dosage was 18-54 micrograms (ug) (3-9 breaths), four times per day (qid) at the time of the event.On (b)(6) 2014, the patient was performing her treatment when the base of the device started smoking.The device then stopped working.No alleged injury.No other information was available.The device was then replaced.The outcome of base started smoking: unknown.Company comments: the company has assessed the serious adverse event of device issue as not related to ih treprostinil.The event was likely related to device malfunction.Reason device not evaluated by mfr: (results pending completion of evaluation).Functional testing of the device was performed.The device displayed "lb" (low battery) error code that could not be cleared and the burning smell / odor was noted.The investigation is in progress at the time of this report.Consumer.Mfr report #: (b)(4).Initial reporter: united states, name and address withheld; consumer.Device manufacture date: 12/2013.

• Brand Name: TYVASO INHALATION SYSTEM
• Type of Device: NONE
• Manufacturer (Section D): UNITED THERAPEUTICS
• MDR Report Key: 4148264
• MDR Text Key: 4913452
• Report Number: MW5038455
• 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: 07/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TD-100 / A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TYVASO (TREPROSTINIL SODIUM) INHALATION GAS; 0.6 MG/ML
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 79