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

Model Number	F10050-A
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Koru medical became aware of mw5176860 received through the fda medwatch program stating " pt reported their pump is broken.Pt reported the syringe kept popping out and would not stay in the pump alone with the black tab/spring is broken.Rph confirmed with pt that they are transferring all of the medication dose into the syringe for administration; pt is not using the manufacturer prefilled syringe directly in the pump with adapter.Rph confirmed with pt the adapter piece is not left in pump and confirmed pt did not connect the f-tubing backwards.No further information, details or dates available.Product lot and expiration unknown.Unknown if md is aware.Dose/amount: hizentra - 31gm.Hizentra indication: myasthenia gravis without (acute) exacerbation; myasthenia gravis with (acute) exacerbation.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." additional information was received providing patient information, however serial number of the device is unknown.The pump listed in this report has not been received by koru medical.Koru medical is currently investigating this event.This event meets the requirements for fda reportability; however, submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.
Additional Manufacturer Narrative
A capa was previously initiated by koru medical to investigate syringe ejection malfunctions.If additional information becomes available, a supplemental report will be filed with the new information.

• 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: 23569572
• Report Number: 1318360-2025-00026
• Device Sequence Number: 9924229
• 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): 11/14/2025

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: F10050-A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/17/2025
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HIZENTRA 20% PFS
• Patient Age: 67 YR
• Patient Sex: Male