MAUDE Adverse Event Report: MINNETRONIX TYVASO INHALATION SYSTEM - NEBULIZER

Model Number TD-100/A

Device Problems Fire (1245); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

[lower level trim] (related symptoms if any separated by commas).Smoke from device [device malfunction].Case description: this case is a spontaneous report from the united states rec'd from a consumer via a specialty pharmacy on (b)(6) 2015.The patient was a (b)(6) male of unreported height and race who first rec'd tyvaso (treprostinil) via inhalation on (b)(6) 2015 for secondary pulmonary hypertension.Inhaled (ih) treprostinil dosage was (b)(6) (3-9 breaths) four times per day at the time of the product problem.Patient initially reported one device (unk serial number) "started smoking and caught on fire." on a follow-up report submitted by the specialty pharmacy, the patient's mother further indicates that during treatment (approximately after the 8 breath) the td-100/a began to smoke.The mother does not know which device or where the smoke was coming from and further stated she could not be sure that it was not coming from the battery pack.The specialty pharmacy shipped two new devices overnight.The device with the alleged deficiency was disposed of by the patient/patient's mother.The device associated with this event was not returned for eval and it was reported that the patient discarded the device.The dhr documentation was reviewed and no evidence was found to indicate a non-conformance to the manufacturing and/or design specs.This case is submitted in the abundance of caution.Device manufacture date: 04/2014.Name and address: united states, name and address withheld.Phone #: withheld.Concomitant medical products: adcirca (tadalafil) ongoing, tyvaso (treprostinil sodium) inhalation gas, 0.6 mg/ml (b)(6) 2015 to unk.

• Brand Name: TYVASO INHALATION SYSTEM - NEBULIZER
• Type of Device: NEBULIZER
• Manufacturer (Section D): MINNETRONIX; st. paul MN
• MDR Report Key: 4949714
• MDR Text Key: 16080415
• Report Number: MW5044867
• Device Sequence Number: 2
• 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: 06/26/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 119