MAUDE Adverse Event Report: MILLYARD ADVANCED MEDICAL PRODUCTS, LLC REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION; INFUSION PUMP

Model Number	DKPI-11036-001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	12/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An initial report of hospitalization was received by united therapeutics drug safety on 16-dec-2024 and forwarded to millyard advanced medical products, llc on 17-dec-2024.The patient reported that she was unable to fill her cassettes and troubleshooting was unsuccessful.The patient was off remodulin for two hours and was feeling anxious but had no other side effects.The patient was admitted to the hospital.There were no reported pump issues.A replacement vial of remodulin was sent.The patient was able to resume remunity therapy and was scheduled to be discharged.No components or further information associated with the reported event have been made available to the manufacturer for further evaluation.Despite no report of death or serious injury, this issue is being reported out of an abundance of caution.

• Brand Name: REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): MILLYARD ADVANCED MEDICAL PRODUCTS, LLC; 540 n. commercial st.; suite 306; manchester NH 03101
• Manufacturer (Section G): MILLYARD ADVANCED MEDICAL PRODUCTS, LLC; 540 n. commercial st.; suite 306; manchester NH 03101
• Manufacturer Contact: tracy ritchie ; 540 n. commercial st.; suite 306; manchester, NH 03101 ; 6032060591
• MDR Report Key: 21103391
• Report Number: 3016798778-2025-00005
• Device Sequence Number: 15619364
• Product Code: QJY
• UDI-Device Identifier: 00850017421073
• UDI-Public: (01)00850017421073
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K202690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DKPI-11036-001
• Device Lot Number: MM900000005238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN; ALDACTONE; AMLODIPINE BESYLATE; CYMBALTA; ESGIC; ESOMEPRAZOLE MAGNESIUM; FLUTICASONE PROPIONATE; GLIMEPIRIDE; LOSARTAN POTASSIUM; MELATONIN; METOPROLOL SUCCINATE; ONDANSETRON HCL; POTASSIUM CHLORIDE; PRESERVISION AREDS; SILDENAFIL CITRATE; TORSEMIDE; TRESIBA FLEXTOUCH U-100; VITAMIN D3; VYTORIN; WINREVAIR; XARELTO
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 90 KG