MAUDE Adverse Event Report: KORU MEDICAL SYSTEMS FREEDOM60®; FREEDOM60 INFUSION PUMP

Model Number	F10050-A
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Arrhythmia (1721); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Nausea (1970); Local Reaction (2035); Voice alteration (4906)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
Koru medical became aware of mw5177924 received through the fda medwatch program stating "(b)(6) home health rn (registered nurse) reported pt (patient) had allergic reaction to hizentra infusion (b)(6) 2025.Rn reported a few minutes into infusion, pt started to feel itchy, rn switched out tape and that is when rn noticed freedom pump malfunctioned and infused the total amount in a few minutes instead of an 1 hour and 43 minutes as expected.Rn confirmed they set up pump with correct tubing/needle set.Pt had hoarse voice, itchiness, redness at infusion sites, nausea and heart palpitations, no shortness of breath.Rn gave iv (intravenous) solumedrol, epi-pen, benadryl, cimetidine and cromolyn.Rn was unable to get iv access to give iv fluids as per anaphylaxis protocol.Rn stayed in pt's home for 3 hours and pt was able to fall asleep.Rn went back to pt's home today for follow up and pt is not having any concerns.All known information is contained on this form.Consent to contact the reporter has not been received, for follow up please contact the prescriber.Pump serial number and expiration unknown.No further information, details or dates available.Product lot and expiration unknown.Unknown if medical doctor is aware.Dose/amount: hizentra 20% prefilled syringe 12 gram.Hizentra indication: common variable immunodeficiency, unspecified; selective deficiency of immunoglobulin g [igg] subclasses; antibody deficiency with nearnormal immunoglobulins or with hyperimmunoglobulinemia.Did pt miss a dose or have an interruption to therapy? unknown.Did adverse event(s) result due to product issue? unknown.Did pharmacy replace device? yes.Is device associated with event available for return? unknown." a good faith effort was sent to the initial reporter on 21-nov-2025 for additional details and pump status.Additional information was received providing patient information, the serial number of the pump involved, and stated the pump has not been returned by the patient.An additional good faith effort was sent on 08-dec-2025 to the initial report to inquire about pump status.The pump listed in this report has not been received by koru medical.Koru medical is currently investigating this event.

• Brand Name: FREEDOM60®
• Common Device Name: FREEDOM60 INFUSION PUMP
• Manufacturer (Section D): KORU MEDICAL SYSTEMS; 100 corporate drive; mahwah NJ
• Manufacturer (Section G): KORU MEDICAL SYSTEMS; 100 corporate drive; mahwah NJ 07430
• Manufacturer Contact: christine trefethen ; 100 corporate drive; mahwah, NJ 07430 ; 8456105572
• MDR Report Key: 23744337
• Report Number: 1318360-2025-00030
• Device Sequence Number: 8835464
• Product Code: FRN
• UDI-Device Identifier: 00659443004450
• UDI-Public: 00659443004450
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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: F10050-A
• Device Lot Number: A.85735
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 12/08/2025
• Date Device Manufactured: 01/08/2024
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HIZENTRA 20% PREFILLED SYRINGE 12 GRAM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female