FDA Adverse Event
Malfunction
Summary report: N
REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
MDR report key: 23535014
·
Received November 12, 2025
Report
- Report Number
- 3016798778-2025-00131
- Event Type
- Malfunction
- Date Received
- November 12, 2025
- Date of Event
- October 11, 2025
- Report Date
- November 12, 2025
- 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
Description of Event or Problem · 0
AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 13-OCT-2025 FROM ACCREDO HEALTH GROUP AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 14-OCT-2025. IT WAS REPORTED THAT THE PATIENT RECEIVED A PUMP FAILURE ALARM WHILE USING ONE OF THEIR REMUNITY PUMPS AND THEIR BACKUP REMUNITY PUMP (B)(6) WOULD NOT TURN ON AFTER BEING DROPPED IN WATER. THE PATIENT WAS HOSPITALIZED AND REPLACEMENT PUMPS WERE COURIERED FROM THE SPECIALTY PHARMACY. NO COMPONENTS OR FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR ADDITIONAL INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2594058 | 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 | 15 YR | Female | Hospitalization | MELATONIN.| NADOLOL.| ONDANSETRON HCL.| SMOFLIPID. |