Remunity Pump for Remodulin (TREPROSTINIL) Injection: medical device reports filed with FDA

373 reports name it, 2022–2026. Manufacturer given most often on reports: Millyard Advanced Medical Products. Product code QJY.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

373
device reports naming the brand: 0% of all MAUDE reports · about 91 a year; 111
reports, 12 months to August 2026: 127 in the 12 months before; 91.2%
classified as malfunction: 74.1% across the product code; 1.3%
classified as death, as reported: 5 reports · not verified by FDA

FDA's MAUDE database holds 373 reports that name the brand "Remunity Pump for Remodulin (TREPROSTINIL) Injection" (infusion pump), received between June 2022 and August 2026; the manufacturer given most often on reports is Millyard Advanced Medical Products. Spellings of one product vary from report to report.

111 reports arrived in the 12 months to August 2026, down 13% from 127 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (91.2%), injury (7.5%) and death (1.3%); across all infusion pump, drug specific, pharmacy-filled reports (product code QJY) death is recorded in 0.8% and malfunction in 74.1%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are insufficient device problem information (60.1%), infusion or flow problem (10.2%) and device contamination with chemical or other material (8%). The patient problems coded most often are dyspnea, dizziness and headache. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

Event type and report source

Event type, as classified on the report

Death1.3%5

Injury7.5%28

Malfunction91.2%340

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%373

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 359 reports carrying product code QJY. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Insufficient device problem information	224	60.1%	40.1%
Infusion or flow problema problem with flow or infusion	38	10.2%	10.9%
Device contamination with chemical or other material	30	8%	2.5%
Mechanical problema mechanical problem	25	6.7%	1.1%
Communication or transmission problemthe device could not communicate or transmit	22	5.9%	7.2%
Wireless communication problema wireless connection problem	14	3.8%	4.2%
False alarm	13	3.5%	3.6%
Fluid/blood leak	13	3.5%	4.7%
Pumping stopped	13	3.5%	3.9%
Intermittent infusion	8	2.1%	2.2%
Excess flow or over-infusion	7	1.9%	2.2%
Failure to infuse	7	1.9%	1.9%
Obstruction of flow	7	1.9%	1.9%
Battery problema problem with the battery	6	1.6%	2.2%
Connection problema connection problem	6	1.6%	2.2%
Detachment of device or device componentpart of the device came off	5	1.3%	1.7%
Leak/splashthe device leaked	5	1.3%	1.9%
Crackthe device cracked	4	1.1%	1.1%
No flow	4	1.1%	1.4%
Unexpected shutdown	4	1.1%	1.1%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Dyspneashortness of breath	43	11.5%
Dizzinesslight-headedness or unsteadiness	18	4.8%
Headachehead pain	17	4.6%
Fatiguetiredness	14	3.8%
Vomitingbeing sick	14	3.8%
Nauseafeeling sick	11	2.9%
Low oxygen saturation	8	2.1%
Chest painchest pain	6	1.6%
Loss of consciousnesspassing out	6	1.6%
Diarrhea	5	1.3%
Hypoxialow oxygen	5	1.3%
Anxietyanxiety	4	1.1%
Hot flashes/flushes	4	1.1%
Lethargysluggishness	4	1.1%
Low blood pressure/ hypotension	4	1.1%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Remunity Pump for Remodulin (TREPROSTINIL) Injection	Product code QJY	All MAUDE reports
Reports	373	359	26,136,888
Share of that pool	—	103.9%	0%
Classified as death, per 1,000 reports	13	8	9
Classified as injury	7.5%	24.8%	36.2%
Classified as malfunction	91.2%	74.1%	62.3%
Filed by the manufacturer	100%	78%	94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Questions about Remunity Pump for Remodulin (TREPROSTINIL) Injection reports

How many FDA reports name Remunity Pump for Remodulin (TREPROSTINIL) Injection?

373 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 111 in the latest 12 months.

What kinds of events are reported?

malfunction (91.2%), injury (7.5%) and death (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (60.1%), infusion or flow problem (10.2%), device contamination with chemical or other material (8%), mechanical problem (6.7%) and communication or transmission problem (5.9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Remunity Pump for Remodulin (TREPROSTINIL) Injection was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.