MAUDE Adverse Event Report: KORU MEDICAL SYSTEMS FREEDOM60 SYRINGE INFUSION SYSTEM; 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	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Koru medical became aware of mw5170949 received through the fda medwatch program stating "indication: nonfamilial hypogammaglobulinemia; other common variable immunodeficiencies; selective deficiency of immunoglobulin a [iga]; hereditary hypogammaglobulinemia.Pt reports syringe would not stay in pump.Pump (serial number and expiration date not provided) kept pushing it out of place multiple times to the point of expelling the entire syringe per pt.After multiple attempts at trying to gauge whether pt was referring to the empty 50 ml syringe or the original 50 ml hizentra, it remained unclear.Pt seemed a bit confused.Pt was advised to dispose of the syringe and not use it as stability could not be assessed.Pt stated she has enough medication on hand.Pharmacy replacing pump.Box sent for return of device associated with event.Availability of pump for investigation dependent on pt's return.No missed dose or interruption to therapy reported.No adverse event(s) reported due to product issue.No further info." 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 SYRINGE INFUSION SYSTEM
• Common Device Name: FREEDOM60 INFUSION PUMP
• Manufacturer (Section D): KORU MEDICAL SYSTEMS; 100 corporate drive; mahwah 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: 22396035
• Report Number: 1318360-2025-00015
• Device Sequence Number: 8573620
• Product Code: FRN
• UDI-Device Identifier: 00659443004450
• UDI-Public: 00659443004450
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

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
• Device Lot Number: A.86766
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/03/2025
• Date Device Manufactured: 03/19/2025
• 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
• Patient Age: 80 YR
• Patient Sex: Female