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

Model Number	DKUT-10006-001; DKUT-21073-007
Medical Device Problem Codes	Fluid/Blood Leak (1250); Infusion or Flow Problem (2964); Wireless Communication Problem (3283)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on 25-mar-2026 from accredo specialty pharmacy, and forwarded to millyard advanced medical products, llc on 26-mar-2026.It was reported that the patient received an alarm after filling the cassette on remunity pro pump, serial number (sn) (b)(6).Upon removing the cassette, medication leaked into the bottom of the pump and into the battery compartment, after which, the pump would not power on or make any sounds, and the remote displayed a "no communication" message.It was also reported that the patient's two previous cassettes had leaked.It was later reported that the patient experienced additional cassette leaks resulting in damage to the pumps, while using remunity pro pumps, sns (b)(6).The patient subsequently experienced an interruption in therapy for approximately 12 hours.Upon troubleshooting, it was discovered that the patient was utilizing the incorrect size needle to fill the cassettes.The patient was advised to remove and discard all of the incorrectly sized needles from their supply.The patient reported that they had one pump on hand that had not been damaged.The patient successfully filled a new cassette and resumed their infusion without further alarms.Replacement pumps and battery kits were issued to the patient.
Additional Manufacturer Narrative
Efforts to obtain additional information from accredo specialty pharmacy are ongoing.It was reported that the patient was utilizing a 25 gauge x 3/8 inch needle to fill their cassettes.Per version 1.9 of the remunity pro user guide, available at the time of the event, patients are advised that only 27 gauge x 3/8 inch or 26 gauge x 3/8 inch needles are approved for filling the remunity pro cassettes.The user guide further cautions patients that supplies provided with previous versions of the remunity system are not compatible with the remunity pro system.This guide also provides the steps to ensure proper technique when filled cassettes.The needles are required for the use of the remunity pro pump, but are not manufactured or distributed by millyard advanced medical products, llc, for use with the device.At this time, no components or additional information have been made available to millyard advanced medical products, llc for further investigation.

• Brand Name: REMUNITYPRO 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: victoria maroon ; 540 n. commercial st.; suite 306; manchester, NH 03101 ; 6032060591
• MDR Report Key: 24987349
• Report Number: 3016798778-2026-00103
• Device Sequence Number: 21449719
• Product Code: FRN
• UDI-Device Identifier: 00850017421219
• UDI-Public: (01)00850017421219(17)20270915
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K250357
• 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): 04/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DKUT-10006-001; DKUT-21073-007
• 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: 03/25/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN ER; ADCIRCA; AMITRIPTYLINE USP; ASPIRIN EC; ATORVASTATIN CALCIUM; BACLOFEN; CELECOXIB; CLONIDINE USP; DILTIAZEM; DULOXETINE HCL; FLUTICASONE PROPIONATE; GABAPENTIN; GABAPENTIN USP; JARDIANCE; KETAMINE HCL USP; KETOPROFEN USP; LECITHIN; LEVONORGESTREL; LIDOCAINE HCL USP; LORAZEPAM; LOSARTAN-HYDROCHLORITHIAZIDE; METFORMIN HCL; OPSUMIT; POLOXAMER GEL; POTASSIUM CHLORIDE; PROTONIX; SERTRALINE HCL; SOD CHLORIDE; TADALAFIL; TORSEMIDE
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 73 KG