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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MINNETRONIX TYVASO INHALATION SYSTEM - NEBULIZER
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MINNETRONIX TYVASO INHALATION SYSTEM - NEBULIZER Back to Search Results
Model Number TD-100/A
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems High Blood Pressure/ Hypertension (1908); Overdose (1988); Sore Throat (2396)
Event Type  Injury  
Event Description
Device is continuously infusing medication [device issue].Throat is sore [sore throat].Feels he received too much medication during his treatment [incorrect dose administered by device].Case description: this case is a spontaneous report from the united states received from a consumer via a specialty pharmacy on (b)(6) 2015.The pt was an adult male, exact age unk (born in 1974), of unk weight, hight and race, who first received tyvaso (treprostinil) via inhalation route on (b)(6) 2014 for pulmonary arterial hypertension.Inhaled (ih) treprostinil dosage was 42 micrograms (mcg) (seven breaths), four times daily, at the time of the events.Inhaled treprostinil was delivered via tyvaso inhalation system - nebulizer.Pt reports device (sn# (b)(4) ) continuously infusing medication (continuous nebulization).Further, the pt 'feels he received too much medication during his treatment and his throat is sore".The pt used 'back-up' device and replacements delivered overnight.(b)(4).Reporter's united states, name and address withheld.Device manufacture date: 11/2013.
 
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Brand Name
TYVASO INHALATION SYSTEM - NEBULIZER
Type of Device
NEBULIZER
Manufacturer (Section D)
MINNETRONIX
st. paul MN
MDR Report Key4922010
MDR Text Key6057086
Report NumberMW5044264
Device Sequence Number1
Product Code CAF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 04/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberTD-100/A
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
0.6 MG/ML - TO ONGOING; TYVASO (TREPROSTINIL SODIUM) INHALATION GAS,
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