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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNITED THERAPEUTICS TYVASO INHALATION SYSTEM; NEBULIZER (DIRECT PATIENT INTERFACE)
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UNITED THERAPEUTICS TYVASO INHALATION SYSTEM; NEBULIZER (DIRECT PATIENT INTERFACE) Back to Search Results
Catalog Number TD300
Device Problems Output Problem (3005); Patient Device Interaction Problem (4001)
Patient Problem Swelling/ Edema (4577)
Event Type  Injury  
Event Description
Pt reports being hospitalized from (b)(6) 2023 due to edema; onset and resolution status/dates of edema unknown.Pt reports they were given an unspecified iv diuretic and is now taking lasix and spironolactone.Pt also reports that during their first week of hospitalization, their tyvaso td300 device showed ¿call support¿ message.Pt¿s spouse brought their back-up device to the hospital for pt to continue tyvaso therapy.After discharge, pt reports they got same ¿call support¿ message on their second td300 device.Neither td300 device is working at this time.Pt only has serial number (b)(4) for the second device; serial number of other device is unknown.Pharmacy will replace both malfunctioning td300 devices.No adverse events due to device malfunctions reported.Unknown if md aware.No further info, details or dates available.Tyvaso nebulizer pt.Pt is actively taking tyvaso, sildenafil, lasix and spironolactone.Reported to cvs/caremark by: patient/caregiver.Reference report: mw5116767.
 
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Brand Name
TYVASO INHALATION SYSTEM
Type of Device
NEBULIZER (DIRECT PATIENT INTERFACE)
Manufacturer (Section D)
UNITED THERAPEUTICS
MDR Report Key16768372
MDR Text Key313778931
Report NumberMW5116768
Device Sequence Number1
Product Code CAF
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Catalogue NumberTD300
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient SexFemale
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