REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
Report
- Report Number
- 3016798778-2025-00047
- Event Type
- Malfunction
- Date Received
- April 30, 2025
- Date of Event
- March 31, 2025
- Report Date
- June 12, 2025
- Manufacturer
- MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
- Product Code
- QJY
- UDI-DI
- 00850017421172
- PMA / PMN Number
- K202690
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
AN INITIAL REPORT OF THE POTENTIAL FOR HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 01-APR-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 02-APR-2025. THE PATIENT REPORTED THAT HER PUMP AND BACKUP PUMP BOTH ALARMED PUMP ERROR AND TROUBLESHOOTING WAS UNSUCCESSFUL. REPLACEMENT PUMPS WERE SENT VIA COURIER. NO ADVERSE SIDE EFFECTS WERE REPORTED. NO COMPONENTS OR FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR FURTHER EVALUATION. DESPITE NO REPORT OF DEATH OR SERIOUS INJURY, THIS ISSUE IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.
AN INITIAL MDR REGARDING THIS CASE WAS FILED 30-APR-2025 (REPORT NUMBER 3016798778-2025-00047). ADDITIONAL INFORMATION WAS RECEIVED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC BY WAY OF A COMPLETED TECHNICAL INVESTIGATION ON RECENTLY RECEIVED MATERIALS THAT WERE IN USE BY THE PATIENT DURING THE REFERENCED EVENT. LOGS FROM REMOTE (B)(6) (PAIRED WITH PUMP (B)(6) SHOW THAT 3 DAYS PRIOR TO AND ON THE DATE OF THE COMPLAINT, THE SYSTEM GENERATED PUMP FAILURE ALARMS. ONE OF THE PUMP FAILURE ALARMS WAS LOGGED WITHOUT A VALID TIMESTAMP. THIS ALARM SIGNATURE HAS BEEN SEEN PREVIOUSLY IN RELATION TO THE PUMP COVER BEING ROTATED FOLLOWED BY THE PUMP BEING POWERED ON, AND THE PUMP EXPECTING A CASSETTE TO BE IN PLACE DUE TO READINGS FROM THE LATCH SENSOR. DURING INVESTIGATION, A TEST DELIVERY WAS COMPLETED WITH NO ABNORMAL BEHAVIOR OBSERVED. THE PUMP WAS DISASSEMBLED FOR FURTHER INVESTIGATION, AND NO ABNORMALITIES WERE OBSERVED. ROOT CAUSE CANNOT BE CONCLUSIVELY CONFIRMED. THE SYSTEM OPERATED AS DESIGNED AND FUNCTIONED WITHIN SPECIFICATION DURING INVESTIGATION. NO DEVICE MALFUNCTIONS WERE OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1182185 | 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 | 58 YR | Female | Hospitalization | ALBUTEROL SULFATE| ALBUTEROL SULFATE| AMIODARONE HCL| AMIODARONE HCL| AMLODIPINE BESYLATE| AMLODIPINE BESYLATE| ASPIRIN| ASPIRIN| ATORVASTATIN CALCIUM| ATORVASTATIN CALCIUM| BENZNIDAZOLE| BENZNIDAZOLE| BENZONATATE| BENZONATATE| DIGOXIN| DIGOXIN| DULOXETINE HCL| DULOXETINE HCL| ENTRESTO| ENTRESTO| FARXIGA| FARXIGA| FEROSUL| FEROSUL| FERROUS SULFATE| FERROUS SULFATE| FLUTICASONE PROPIONATE| FLUTICASONE PROPIONATE| FUROSEMIDE| FUROSEMIDE| GABAPENTIN| GABAPENTIN| LANTUS SOLOSTAR| LANTUS SOLOSTAR| METFORMIN ER GASTRIC| METFORMIN ER GASTRIC| OXYCODONE-ACETAMINOPHEN| OXYCODONE-ACETAMINOPHEN| OXYGEN| OXYGEN| OZEMPIC .25 OR| OZEMPIC .25 OR| POTASSIUM CHLORIDE| POTASSIUM CHLORIDE| PREGABALIN| PREGABALIN| PROMETHAZINE-DM| PROMETHAZINE-DM| PROTONIX| PROTONIX| SALINE| SALINE| SPIRONOLACTONE| SPIRONOLACTONE| STERILE WATER FOR INJ| STERILE WATER FOR INJ| WINREVAIR| WINREVAIR| XYZAL| XYZAL |