FDA Adverse Event
Malfunction
Summary report: N
REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
MDR report key: 24643417
·
Received March 19, 2026
Report
- Report Number
- 3016798778-2026-00061
- Event Type
- Malfunction
- Date Received
- March 19, 2026
- Date of Event
- February 17, 2026
- Report Date
- March 19, 2026
- Manufacturer
- MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
- Product Code
- QJY
- UDI-DI
- 00850017421035
- PMA / PMN Number
- K202690
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM CVS SPECIALTY PHARMACY WERE UNSUCCESSFUL. AT THE TIME OF THIS REPORT, NO COMPONENTS OR ADDITIONAL INFORMATION HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR FURTHER INVESTIGATION.
Description of Event or Problem · 0
AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 18-FEB-2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 19-FEB-2026. IT WAS REPORTED THAT THE PATIENT'S REMUNITY PUMPS WERE NOT FUNCTIONING AS EXPECTED, WHICH RESULTED IN AN INTERRUPTION IN THERAPY. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL. NO FURTHER INFORMATION REGARDING THE TYPE OF DEVICE ISSUE WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 705264 | REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION | INFUSION PUMP | QJY | MILLYARD ADVANCED MEDICAL PRODUCTS, LLC | DKPI-11042-001 | 00850017421035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Female | Hospitalization | OPSUMIT |