FDA Adverse Event
Malfunction
Summary report: N
REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
MDR report key: 23655942
·
Received November 26, 2025
Report
- Report Number
- 3016798778-2025-00136
- Event Type
- Malfunction
- Date Received
- November 26, 2025
- Date of Event
- October 28, 2025
- Report Date
- November 26, 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
NOTIFICATION OF A REPORTABLE EVENT WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 17-NOV-2025 FROM ACCREDO HEALTH GROUP AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 18-NOV-2025. IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO THE HOSPITAL AFTER RECEIVING A PUMP FAILURE ALARM FROM THEIR REMUNITY PUMP, (B)(6), AND A MESSAGE TO SWITCH TO THEIR BACKUP REMUNITY SYSTEM. THE PATIENT WAS SWITCHED TO THEIR BACKUP REMUNITY PUMP AS ADVISED. 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 |
|---|---|---|---|---|---|---|---|
| 2569672 | 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 | 26 MO | Female | Other | ACTIVASE| AMBRISENTAN| DOCUSATE SODIUM| FUROSEMIDE| HAVRIX| M-M-R II VACCINE| MULTIVITAMINS WITH IRON TABLET| OXYGEN| PENTACEL| SOLU-MEDROL| TADLIQ| VARIVAX VACCINE |