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

Model Number	F10050
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 mw5176432 received through the fda medwatch program stating "pt stated that she was going to do her second infusion for the week earlier this morning around 8am and was having trouble with the pump.She said she had everything set up but infusion wouldn't start.She took the syringe out, placed it back in and tried to rewind the pump but it wasn't making the windup noise she normally hears and the syringe spit out.She put the syringe in the fridge and went to work.Initially recommended to try to do manual push of med since no volume was lost and still within 8hr time frame but patient placed syringe in fridge and we have no stability data on cutaquig once placed in fridge after being at room temp.Advised i will reach out to md to see if they want to provide makeup dose or if she should skip this second dose and resume normal schedule next week (sunday).No further questions for rph.No further information provided.Serial number (b)(6).1.Did the reported product fault occur while in use with the patient? yes.2.Did the product issue cause or contribute to patient or clinical injury? no.3.Is the actual device available for investigation? not reported.4.Did we replace the device? yes." additional information was received providing patient information and the serial number of the pump involved.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 07430
• 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: 23555020
• Report Number: 1318360-2025-00022
• Device Sequence Number: 10114534
• Product Code: FRN
• UDI-Device Identifier: 00659443000001
• UDI-Public: 00659443000001
• 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
• Device Lot Number: S.82047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2021
• 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: CUTAQUIG SDV
• Patient Age: 37 YR
• Patient Sex: Female