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 Codes	Fluid/Blood Leak (1250); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on 10-nov-2025 from accredo health group and forwarded to millyard advanced medical products, llc, on 11-nov-2025.The patient reported being out of remodulin since 1:00 am on (b)(6) 2025.It was communicated that the patient's medication vial was leaking, and that their last remunity cassette had leaked while filling.The patient also reported that their son had to disconnect their tubing, but they had no additional supplies on hand.Accredo health group reported that no remunity product is available for return.Reportable information related to this event was later received by united therapeutics drug safety on 10-nov-2025 from accredo health group and forwarded to millyard advanced medical products, llc, on 14-nov-2025.This information indicated that the patient was admitted to the hospital on (b)(6) 2025.Attempts made to obtain additional information from accredo health group were unsuccessful.
Additional Manufacturer Narrative
No further information related to the reported event has been made available to millyard advanced medical products, llc, for additional investigation.It is unknown if the tubing referred to in the initial event is associated with the infusion set (not manufactured or distributed by millyard advanced medical products, llc) or the remunity cassette.Therefore, the difficulty disconnecting the tubing is conservatively addressed in this report.The medication vial is not manufactured or distributed by millyard advanced medical products, llc; therefore, the leaking from the medication vial is not addressed in this report.

• Brand Name: REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): MILLYARD ADVANCED MEDICAL PRODUCTS, LLC; 540 n. commericial st.; suite 306; manchester NH 03101
• Manufacturer (Section G): MILLYARD ADVANCED MEDICAL PRODUCTS, LLC; 540 n. commericial st.; suite 306; manchester NH 03101
• Manufacturer Contact: courtney mcguirk ; 540 n. commercial st.; suite 306; manchester, NH 03101 ; 6032060591
• MDR Report Key: 23771648
• Report Number: 3016798778-2025-00142
• Device Sequence Number: 9722810
• Product Code: QJY
• UDI-Device Identifier: 00850017421073
• UDI-Public: (01)00850017421073
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALLEGRA HIVES; AMITRIPTYLINE USP; CLONIDINE USP; DICYCLOMINE HCL; FLONASE ALLERGY RELIEF; GABAPENTIN USP; IMODIUM; KETAMINE HCL USP; KETOPROFEN USP; LECITHIN; LIDOCAINE HCL USP; LIPITOR; METFORMIN ER GASTRIC; METOPROLOL SUCCINATE; MULTIVITAMIN; OMEGA-3 + D; OXYGEN; POLOXAMER GEL; SOD CHLORIDE; SYNTHROID; TADALAFIL; TORSEMIDE; TRAZODONE HCL; ZOLOFT
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 64 KG