REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
Report
- Report Number
- 3016798778-2026-00129
- Event Type
- Malfunction
- Date Received
- May 15, 2026
- Date of Event
- April 13, 2026
- Report Date
- May 15, 2026
- Manufacturer
- MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
- Product Code
- QJY
- UDI-DI
- 00850017421172
- PMA / PMN Number
- K202690
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE INVESTIGATION INTO THE REPORTED EVENT IS CURRENTLY ONGOING. A FOLLOW-UP REPORT CONTAINING THE RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON ITS COMPLETION. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR FURTHER INVESTIGATION.
AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 15-APR-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 18-APR-2026. IT WAS REPORTED THAT THE PATIENT'S REMUNITY PUMP (SERIAL NUMBER: (B)(6) STOPPED INFUSING AND THE REMOTE (SERIAL NUMBER: (B)(6) DISPLAYED A "SEARCHING" MESSAGE. THE PATIENT EXPERIENCED AN INTERRUPTION IN THERAPY FOR AN UNKNOWN PERIOD OF TIME AND STATED THAT THEY DID NOT HAVE A FUNCTIONAL BACKUP SYSTEM ON HAND. THE PATIENT WAS ULTIMATELY HOSPITALIZED ON (B)(6) 2026 AND DISCHARGED ON (B)(6) 2026.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 429707 | REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION | INFUSION PUMP | QJY | MILLYARD ADVANCED MEDICAL PRODUCTS, LLC | DKPI-11094-001 | 00850017421172 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female | Hospitalization | CARVEDILOL.| POTASSIUM CHLORIDE.| TORSEMIDE. |